Dimethyl sulfoxide (DMSO) wet bonding has shown promising results in several in vitro studies. However, there are a lack of clinical trials which prove the advantages of this technique. The aim of the study is to clinically assess the effect of DMSO wet bonding on composite restoration in non carious cervical lesions.

Start Date20 Oct 2024

Sponsor / Collaborator-

CTR20230607 / RecruitingNot Applicable

评价二甲基亚砜冲洗液膀胱内灌注治疗间质性膀胱炎（Hunner型）有效性和安全性的一项多中心、随机、双盲、安慰剂平行对照验证性临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled confirmatory clinical study to evaluate the efficacy and safety of intravesical instillation of dimethyl sulfoxide irrigation solution in the treatment of interstitial cystitis (Hunner type)

主要研究目的：评价膀胱内灌注二甲基亚砜冲洗液治疗间质性膀胱炎（Hunner型）的有效性。次要研究目的：评价膀胱内灌注二甲基亚砜冲洗液治疗间质性膀胱炎（Hunner型）的安全性。

[Translation]

Primary study objective: To evaluate the effectiveness of intravesical instillation of dimethyl sulfoxide irrigation solution in the treatment of interstitial cystitis (Hunner type). Secondary study objective: To evaluate the safety of intravesical instillation of dimethyl sulfoxide irrigation solution in the treatment of interstitial cystitis (Hunner type).

Start Date26 Jul 2023

Sponsor / Collaborator

Jiangsu Langyan Life Technology Holdings Co., Ltd.

CTR20230609 / RecruitingNot Applicable

评价二甲基亚砜冲洗液膀胱内灌注治疗间质性膀胱炎（非Hunner型）有效性和安全性的一项多中心、随机、双盲、安慰剂平行对照验证性临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-group confirmatory clinical study to evaluate the efficacy and safety of intravesical instillation of dimethyl sulfoxide irrigation solution in the treatment of interstitial cystitis (non-Hunner type)

主要研究目的：评价膀胱内灌注二甲基亚砜冲洗液治疗间质性膀胱炎（非Hunner型）的有效性。次要研究目的：评价膀胱内灌注二甲基亚砜冲洗液治疗间质性膀胱炎（非Hunner型）的安全性。

[Translation]

Primary study objective: To evaluate the effectiveness of intravesical instillation of dimethyl sulfoxide irrigation solution in the treatment of interstitial cystitis (non-Hunner type). Secondary study objective: To evaluate the safety of intravesical instillation of dimethyl sulfoxide irrigation solution in the treatment of interstitial cystitis (non-Hunner type).

Start Date08 May 2023

Sponsor / Collaborator

Jiangsu Langyan Life Technology Holdings Co., Ltd.

100 Clinical Results associated with Dimethyl Sulfoxide

100 Translational Medicine associated with Dimethyl Sulfoxide

100 Patents (Medical) associated with Dimethyl Sulfoxide

8,042

Literatures (Medical) associated with Dimethyl Sulfoxide

01 Mar 2025·CRYOBIOLOGY

No synergistic effect of extracellular cryoprotectants with dimethyl sulfoxide in the conservation of northern tiger cat fibroblasts

Article

Author: Alves, Patrícia Vasconcelos ; Pereira, Antonia Beatriz Mendonça ; Viana, João Vitor da Silva ; Moura, Yasmin Beatriz França ; Silva, Herlon Victor Rodrigues ; Pereira, Alexsandra Fernandes ; Oliveira, Lhara Ricarliany Medeiros de ; Rodrigues, Luanna Lorenna Vieira

The success of somatic cell cryobanks is dependent on establishing reproducible cryopreservation methodologies. We supposed that associated extracellular cryoprotectants (sucrose and L-proline) with 2.5 or 10 % dimethyl sulfoxide (Me₂SO) could guarantee better northern tiger cat cells quality rates after thawing when compared to Me₂SO alone. Therefore, we evaluated the effects of sucrose or L-proline with 2.5 or 10 % Me₂SO on the cryopreservation of northern tiger cat fibroblasts. Somatic cells were also cryopreserved with 2.5 % or 10 % Me₂SO alone. All cells were analyzed for morphology, membrane integrity, proliferative activity, metabolism, apoptosis classification, reactive oxygen species (ROS) levels, and mitochondrial membrane potential (ΔΨm). Regardless of the cryoprotective solution, cryopreservation did not affect morphology, membrane integrity after culture, proliferative activity, and metabolism (P > 0.05). However, immediately after thawing, 2.5 % Me₂SO with L-proline and 10 % Me₂SO promoted higher rates of membrane integrity when compared to the other cryopreserved groups (P < 0.05). Interestingly, cells cryopreserved with 10 % Me₂SO maintained ROS levels similar to non-cryopreserved cells (P > 0.05). However, the percentage of viable cells evaluated by apoptosis classification was reduced when using 10 % Me₂SO with L-proline compared to non-cryopreserved groups (P < 0.05). Additionally, ΔΨm was altered in all cryopreserved groups (P < 0.05). In summary, sucrose and L-proline were less effective in cryopreservation of northern tiger cat fibroblasts in the presence of 2.5 % or 10 % Me₂SO. Also, 10 % Me₂SO appears to be the most suitable cryoprotectant for the formation of cryobanks of this species.

01 Mar 2025·CRYOBIOLOGY

Glycerol improves the viability of a cryopreserved choanoflagellate

Article

Author: Chandra, Sheel ; Rutaganira, Florentine U

The colonial choanoflagellate Salpingoeca rosetta is a tractable model system for studying the origins of multicellularity, but long-term storage strategies for this species have not been tested. In this study, we probed each stage of cryopreservation (cooling, long-term storage, recovery) to identify the optimal protocol for recovery of S. rosetta and co-cultured bacterial cells. Dimethyl sulfoxide (Me2SO; commonly referred to as DMSO), the current cryoprotective agent (CPA) standard, proved to be worse than glycerol at comparable concentrations. Samples treated with either CPA at 5 % showed the poorest recovery. Our results identified 15 % glycerol as the most effective CPA for both S. rosetta and Echinicola pacifica. We also determined that ultra-low temperature freezers can be sufficient for short-term storage. We propose 15 % glycerol and liquid phase nitrogen as the standard cryopreservation protocol for S. rosetta cultures and as a starting point for testing long-term storage strategies for other choanoflagellates and heterotrophic protists.

01 Feb 2025·Current computer-aided drug design

Exploring the Mechanisms of Sanguinarine in the Treatment of Osteoporosis by Integrating Network Pharmacology Analysis and Deep Learning Technology

Article

Author: Gan, Fengping ; Zhou, Daoqing ; Zeng, Yuqing ; Tang, Yonghong ; Yao, Zhicheng

Background::

Sanguinarine (SAN) has been reported to have antioxidant, antiinflammatory, and antimicrobial activities with potential for the treatment of osteoporosis (OP).

Objective::

This work purposed to unravel the molecular mechanisms of SAN in the treatment of OP.

Methods::

OP-related genes and SAN-related targets were predicted from public databases. Differential expression analysis and VennDiagram were adopted to detect SAN-related targets against OP. Protein-protein interaction (PPI) network was served for core target identification. Molecular docking and DeepPurpose algorithm were further adopted to investigate the binding ability between core targets and SAN. Gene pathway scoring of these targets was calculated utilizing gene set variation analysis (GSVA). Finally, we explored the effect of SAN on the expressions of core targets in preosteoblastic MC3T3-E1 cells.

Results::

A total of 21 candidate targets of SAN against OP were acquired. Furthermore, six core targets were identified, among which CASP3, CTNNB1, and ERBB2 were remarkably differentially expressed in OP and healthy individuals. The binding energies of SAN with CASP3, CTNNB1, and ERBB2 were -6, -6.731, and -7.162 kcal/mol, respectively. Moreover, the GSVA scores of the Wnt/calcium signaling pathway were significantly lower in OP cases than in healthy individuals. In addition, the expression of CASP3 was positively associated with Wnt/calcium signaling pathway. CASP3 and ERBB2 were significantly lower expressed in SAN group than in DMSO group, whereas the expression of CTNNB1 was in contrast.

Conclusion::

CASP3, CTNNB1, and ERBB2 emerge as potential targets of SAN in OP prevention and treatment.

News (Medical) associated with Dimethyl Sulfoxide

18 Dec 2024

·www.prnewswire.com

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease

SILVER SPRING, Md., Dec. 18, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older. Ryoncil is the first FDA-approved MSC therapy. It contains MSCs, which are a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isolated from the bone marrow of healthy adult human donors. "Today's decision marks an important milestone in the use of innovative cell-based therapies to treat life-threatening diseases with devastating impacts on patients, including children," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER). "This first mesenchymal stromal cell therapy approval demonstrates the FDA's commitment to supporting the development of safe and effective products that could improve the quality of life for patients with symptoms that are unresponsive to other therapies." Steroid-refractory acute graft-versus-host disease is a serious and life-threatening condition that can occur as a complication of allogeneic hematopoietic (blood) stem cell transplantation (allo-HSCT). In allo-HSCT, a patient receives hematopoietic stem cells from a healthy donor to replace their own stem cells and form new blood cells, a procedure often done as part of treatment for certain types of blood cancers, blood disorders or immune system disorders. "Steroid-refractory acute graft-versus-host disease can have significant, wide-ranging health consequences, including damage to multiple organs, reduced quality of life and risk of death in affected patients," said Nicole Verdun, M.D., director of the Office of Therapeutic Products in CBER. "The FDA remains dedicated to helping address the urgent unmet needs of individuals with debilitating and deadly diseases, and today's approval is an important step in that effort." The safety and effectiveness of Ryoncil were evaluated in a multicenter, single-arm study in 54 pediatric study participants with SR-aGVHD after undergoing allo-HSCT. Study participants received intravenous infusion of Ryoncil twice weekly for four consecutive weeks, for a total of eight infusions. Each study participant's condition at baseline was analyzed using the International Blood and Marrow Transplantation Registry Severity Index Criteria (IBMTR) to evaluate which organs have been affected and the overall severity of the disease. Ryoncil's effectiveness was based primarily on the rate and duration of response to treatment 28 days after initiating Ryoncil. Study participants who had a partial or mixed response to treatment—meaning that there was improved condition in one organ with either no change (partial) or worsening condition (mixed) in another organ—received additional infusions once weekly for an additional four weeks. Sixteen study participants (30%) had a complete response to treatment 28 days after receiving Ryoncil, while 22 study participants (41%) had a partial response. Infusion of Ryoncil should be monitored by the treating physician, and the infusion should be discontinued if there is any evidence of a reaction which may include dyspnea (shortness of breath), hypotension (low blood pressure), fever, tachypnea (rapid breathing), cyanosis (blue discoloration of skin, lips or nails) and hypoxia (low oxygen in the blood). The most common adverse reactions in study participants who received Ryoncil were infections, fever, hemorrhage, edema, abdominal pain and hypertension. Complications such as hypersensitivity and acute infusion reactions, transmission of infectious disease or agents and ectopic tissue formation may occur following treatment with Ryoncil. Ryoncil is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide or porcine and bovine proteins. Patients should be premedicated with corticosteroids and antihistamines prior to infusion and monitored for hypersensitivity reactions during treatment with Ryoncil. The application received Orphan Drug, Fast Track and Priority Review designations by the FDA. The FDA granted approval of Ryoncil to Mesoblast, Inc. Media Contact: Carly Pflaum, (240) 672-8872 Consumer Inquiries: Email or 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackClinical ResultCell TherapyOrphan DrugDrug Approval

23 Feb 2024

·www.globenewswire.com

Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

Expanded access program (EAP) data for omidubicel are consistent with Phase 3 trial results on rates of hematopoietic recovery and infections following stem cell transplant with Omisirge® (omidubicel-onlv) Preliminary data presented on GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing Phase 1 study for non-Hodgkin lymphoma, show promising early evidence of anti-tumor activity BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas. “The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “The EAP study provided the opportunity to treat patients after completion of enrollment of the Phase 3 trial and prior to the approval of Omisirge. It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment. Data were consistent with previous studies, showing that patients transplanted with omidubicel had rapid hematopoietic recovery and a low rate of serious infections post-transplant.” “The Phase 1 data on our natural killer (NK) cell candidate GDA-201 further support the anti-tumor activity of our NAM-enhanced cellular therapy, and today marked the first presentation of study results using our cryopreserved, readily available formulation,” Simantov added. Reporting on omidubicel’s EAP data, principal investigator Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute, said, “I am highly encouraged by the results in the omidubicel expanded access program. The potential for rapid hematopoietic recovery post-transplant observed with omidubicel could make a meaningful impact on patient health. I am pleased to see that the EAP results are consistent with data from the Phase 3 study.” Additional details on the presentations are as follows: Title: Omidubicel-onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP)Abstract Number: 313Lead Author: Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer InstituteTime: February 22, 6:45-7:45 p.m. CT Presentation highlights: In this expanded access program (EAP) evaluating outcomes in 29 patients with hematologic malignancies following allogeneic hematopoietic stem cell transplant with omidubicel, outcomes were overall consistent with those from omidubicel’s Phase 3 study. Eligible patients ≥12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Median time to neutrophil and platelet engraftment were 12 and 34 days, respectively. Results were also similar to the Phase 3 study for infection (first grade 2-3 bacterial / invasive fungal infections at 100 days posttransplant: 18%), graft-versus-host-disease (grades 3-4: 19%), disease-free survival (79%) and overall survival (87%). Demographics of transplanted patients were 55% White, 21% Asian, 17% Black, and 7% other, consistent with the Phase 3 trial, in which >40% of the study participants were racially or ethnically diverse. Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant. Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell LymphomaAbstract Number: 255Lead Author: Brian C. Shaffer, Associate Professor of Medicine and Head of the Adult Mismatched Donor Sub-Program at Memorial Sloan Kettering Cancer Center in New YorkDate and Time: February 22, 6:45-7:45 p.m. CT Presentation highlights: In this ongoing multicenter Phase 1 study of allogeneic cryopreserved NK cell therapy candidate GDA-201 in patients with relapsed/refractory B-cell CD20 positive non-Hodgkin lymphoma, preliminary data for the first 12 patients were presented. Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant. Patients were treated with doses up to 2x108 cells/kg GDA-201 in combination with rituximab. There were no infusion reactions, dose-limiting toxicities or related serious adverse events. Seven patients exhibited a decrease in tumor burden. Efficacy evaluation using Lugano criteria showed three patients with complete response, two with partial response and two with stable disease. Cytokine release syndrome was reported in two patients (grade 1 and grade 2, respectively). There were no cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease reported. Treatment and evaluation of patients in the fourth cohort of the study at the highest dose level of 2x108 cells/kg is ongoing. Full results are expected in Q1 2024. Posters are available at: https://www.gamida-cell.com/our-rd/ About Gamida CellGamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram. About GDA-201GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. NAM-modified NK cells have previously been shown to have enhanced metabolic fitness, resistance to oxidative stress and potent cytotoxicity. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024. GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. Omisirge® (omidubicel-onlv) IndicationOmisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Important Safety Information for Omisirge BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. ContraindicationsOMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Warnings and PrecautionsHypersensitivity ReactionsAllergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration. Infusion ReactionsInfusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Graft-versus-Host DiseaseAcute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops. Engraftment SyndromeEngraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death. Graft FailurePrimary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery. Malignancies of Donor OriginTwo patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478. Transmission of Serious InfectionsTransmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478. Transmission of Rare Genetic DiseasesOMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited. ADVERSE REACTIONSThe most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction. Please see full Prescribing Information, including Boxed Warning. About Gamida CellGamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Facebook, X and Instagram. Cautionary Note Regarding Forward-Looking StatementsThis press release may contain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), and the Company’s cell therapy candidate, GDA-201. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements. Omisirge® is a registered mark of Gamida Cell Inc. © 2024 Gamida Cell Inc. All Rights Reserved. Media Contact:  Dan Boyle  Orangefiery  media@orangefiery.com1-818-209-1692  Investor Contact:  Chuck Padala  LifeSci Advisors  Chuck@lifesciadvisors.com1-646-627-8390

Clinical ResultCell TherapyPhase 3Phase 1ASH

17 Jan 2024

·www.biospace.com

Gamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

BOSTON, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced it will present new data on its FDA approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24. Additional details about the poster presentations are as follows: Title: Omidubicel-onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP) Abstract Number: 313 Lead Author: Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute Time: February 22, 6:45-7:45 p.m. ET Abstract highlights: An Expanded Access Program (EAP) evaluated outcomes in 29 patients with hematologic malignancies following allo-HCT with omidubicel. Eligible patients ≥12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Results demonstrated rapid hematopoietic recovery and low rate of infections. Safety and efficacy, including relapse, disease-free survival and overall survival, were similar to those observed in the Phase 3 study of omidubicel. Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant. Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell Lymphoma Abstract Number: 255 Lead Author: Brian C. Shaffer, Associate Professor of Medicine and Head of the Adult Mismatched Donor Sub-Program at Memorial Sloan Kettering Cancer Center in New York Date and Time: February 22, 6:45-7:45 p.m. ET Abstract highlights: This is an ongoing multicenter Phase 1 study of allogeneic cryopreserved NK cell therapy candidate GDA-201 in patients with relapsed/refractory B-cell CD20 positive non-Hodgkin lymphoma. Preliminary data for the 10 patients enrolled in the first three of four total cohorts, who were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant, showed no infusion reactions, dose limiting toxicities or related serious adverse events reported in patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab. Marked shrinkage of target lesions was observed in five patients and efficacy evaluation showed two patients with complete response, two with partial response and one with stable disease. Two patients treated had cytokine release syndrome. There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease. About GDA-201 GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024. GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. Omisirge® (omidubicel-onlv) Indication Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Important Safety Information for Omisirge BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material. Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD. Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids. Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Contraindications OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Warnings and Precautions Hypersensitivity Reactions Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration. Infusion Reactions Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Graft-versus-Host Disease Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops. Engraftment Syndrome Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death. Graft Failure Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery. Malignancies of Donor Origin Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478. Transmission of Serious Infections Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478. Transmission of Rare Genetic Diseases OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited. ADVERSE REACTIONS The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction. Please see full Prescribing Information, including Boxed Warning. About Gamida Cell Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit or follow Gamida Cell on LinkedIn, Facebook, X and Instagram. Cautionary Note Regarding Forward-Looking Statements This press release may contain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), and the Company’s cell therapy candidate, GDA-201. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at ), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements. Omisirge® is a registered trademark of Gamida Cell Inc. © 2024 Gamida Cell Inc. All Rights Reserved. Media Contact: Dan Boyle Orangefiery media@orangefiery.com 1-818-209-1692 Investor Contact: Chuck Padala LifeSci Advisors Chuck@lifesciadvisors.com 1-646-627-8390

100 Deals associated with Dimethyl Sulfoxide

External Link

KEGG	Wiki	ATC	Drug Bank
D01043	Dimethyl Sulfoxide	M02AX03 G04BX13	DB01093

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cystitis, Interstitial	US	Mylan Institutional LLC	04 Apr 1978

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Lung	Preclinical	TW	Fu Jen Catholic University	15 Apr 2011
Leukemia	Preclinical	KR	Samsung Medical Center	15 Jul 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P706 (EBMT2020)	Not Applicable	-	10	DMSO (Fresenius Kabi LOVO Cell Processing System)	teeynpscow(kqdejpsjzb) = Percentage of CD34 viability tends to increase after washing with a mean increase of 9.9% xibvetozff (rpaoejucsi ) View more	Positive	29 Aug 2020
ASCO2017	Not Applicable	Seizures	982	Dimethyl sulfoxide (DMSO) (DMSO cryopreserved stem cell infusion)	dkiqijhere(sftniaviok) = All 5 pts developed seizures during SCI nrulenxnmo (cygalayziq )	-	30 May 2017
EHA2015	Not Applicable	FLT3-ITD/TKD-mutant Haematological Malignancies	118	AUTOLOGOUS PERIPHERAL BLOOD CD34+ CRYOPRESERVED WITH 5% DIMETHYL SULFOXIDE COMPARED TO 10% (5% DMSO)	gsbizxawdm(inqhkumefn) = hnttvarfdz avvvijskoh (kzvmlnpswg ) View more	-	21 May 2015
				AUTOLOGOUS PERIPHERAL BLOOD CD34+ CRYOPRESERVED WITH 5% DIMETHYL SULFOXIDE COMPARED TO 10% (10% DMSO)	gsbizxawdm(inqhkumefn) = iecldbselr avvvijskoh (kzvmlnpswg ) View more
NCT00667095 (CTgov)	Phase 3	Neurogenic detrusor overactivity \| Urinary Incontinence, Urge \| Overactive bladder syndrome	25	Botox Instillation+DMSO Instillation (Botox and DMSO Instillation)	ygfxhlicpl(zqlhvooafz) = mwqxaqpdrc htnpypfoqn (eaezperlqm, xspafyezga - faqtqqbgux) View more	-	11 Jul 2014
				DMSO Instillation (DMSO Instillation)	ygfxhlicpl(zqlhvooafz) = jdprphpppd htnpypfoqn (eaezperlqm, zlrprmndos - ytmyvxofzh) View more
ARVO2014	Not Applicable	Retinal Degeneration	-	Vehicle (Dulbecco’s PBS)	hnztdwqcdy(vsucktrawm) = ztuqoyqnwx epesfsxivp (uyldkdlwrc ) View more	-	01 Apr 2014
				Vehicle containing DMSO (3.74 g/kg)	hnztdwqcdy(vsucktrawm) = zjclcrhycn epesfsxivp (uyldkdlwrc, 8.4) View more
Tandem Meetings ASTCT and CIBMTR2013	Not Applicable	Graft Rejection	-	DMSO	dgzgdenxju(kyulnfhkqe) = at doses of 30 - 40 mg/kg in animals gsjynbakrk (mmzemwdrhl ) View more	-	01 Feb 2013
				Intravenous DMSO (Stem cell transplant patients)
ERA2012	Not Applicable	Acute Kidney Injury	-	DMSO lower than 10%	uetfvazbyp(nvwcpblxyp) = vugavukjwd jokpmebtzx (fizmqdvmjt )	-	01 May 2012
				Vancomycin	uetfvazbyp(nvwcpblxyp) = hsvfjndzvt jokpmebtzx (fizmqdvmjt )

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