RegulationOrphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Regenerative Medicine Advanced Therapy (United States), Accelerated assessment (European Union), Advanced Therapy Medicinal Products (European Union)

Clinical Trials associated with Stem cell therapeutics (ExCellThera)

NCT04990323

/ RecruitingPhase 1/2

A Phase I/II Open-Label Study of ECT-001-Expanded Cord Blood Transplantation in Pediatric and Young Adult (<21year) Patients With High-Risk and Very High-Risk Myeloid Malignancies

Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality. UM171, a novel and potent agonist of hematopoietic stem cell self renewal could solve this major limitation, allowing for CB's important qualities as lower risk of chronic GVHD and relapse to prevail. In previous trials (NCT02668315, NCT03913026, NCT04103879, and NCT03441958), the CB expansion protocol using the ECT-001-CB technology (UM171 molecule) has proven to be technically feasible and safe in adults.
UM171 expanded CB was associated with a prompt (D+17), robust (98%) and durable neutrophil recovery. Amongst patients who received a single UM171 CB transplant with a median follow-up of 18 months, risk of TRM (10%), grade 3-4 acute GVHD (13%) and moderate-severe chronic GVHD (2%) was low at 1 year post-transplant. Incidence of severe viral and bacterial infections was reduced and immunosuppression could be discontinued in 77% of patients at 1 year. Thus, PFS and GRFS were very promising, 72% and 59% at 12 months, 69% and 53% at 24 months, respectively, in particular accounting for a large proportion of very high-risk patients. By a 10-fold increase of CB accessibility, ECT-001-CB allowed access to smaller, better HLA matched CBs.
This new study seeks to test a similar strategy in a group of pediatric and young adult patients with high risk myeloid malignancies. 12 patients will be enrolled in the first stage of this 2-stage design protocol. If intervention is considered promising (<= 3 relapses in the first 12 patients), this study will open multicenter and be extended to a second stage (16 additional patients for a total accrual 28).

Start Date01 Dec 2021

Sponsor / Collaborator

ExCellThera, Inc.

[+1]

NCT04594031

/ WithdrawnPhase 1

A Phase I Multicenter Study of Hematopoietic Stem Cell Transplant of ECT-001-Expanded Cord Blood With a Reduced Toxicity Conditioning Regimen in Patients With Severe Sickle Cell Disease

The application of experimental hematopoietic cell transplantation (HCT) therapy in sickle-cell disease (SCD) must strike a balance between the underlying disease severity and the possibility of a direct benefit of the treatment, particularly in pediatric populations. Clinical studies in adults with SCD have focused on interventions that prolong survival and improve the quality of life. Unlike children, adults with SCD are much more likely to have a debilitating complication. As a result, the risk/benefit ratio of HCT is very favorable in adults, particularly if an approach to HCT that defines an acceptable level of toxicity can be established.
Whereas hematopoietic stem cell transplantation (HSCT) remains the only curative treatment currently available for patients with SCD, the morbidity, the frequent irreversible damage in target organs and the mortality reported in the natural course of patients with severe SCD are strong incentives to perform HSCTs in younger age groups. For those who lack a matched related donor, CB transplant is an appealing option, but despite been less problematic, CB accessibility related to cell dose of appropriately matched cord blood unit (CBU) remains a significant issue. Through a 7-day culture process of a CBU's hematopoietic stem cell HSCs with the UM171 compound, the total cell dose is increased mitigating this limitation.
UM171-CB expansion (ECT-001-CB) allows a greater CB accessibility, the selection of better matched cords that might translate into favourable clinical outcomes as reported in previous trials, including a lower risk of graft-versus-host disease. After CB selection and ex-vivo expansion, ECT-001-CB transplant will follow a myeloablative reduced-toxicity conditioning regimen consisting of rATG, busulfan and fludarabine with doses of all agents optimized to the individual using model-based dosing and will be followed by standard supportive care and GVHD prophylaxis consisting of tacrolimus and MMF.

Start Date13 Jul 2021

Sponsor / Collaborator

ExCellThera, Inc.

[+1]

NCT04103879

/ Active, not recruitingPhase 2

A Phase II Open-Label Study of UM171-Expanded Cord Blood Transplantation in Patients With High and Very High Risk Acute Leukemia/Myelodysplasia

Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality. UM171, a novel and potent agonist of hematopoietic stem cell self renewal could solve this major limitation, allowing for CB's important qualities as lower risk of chronic GVHD and relapse to prevail. In a previous trial (NCT02668315), the CB expansion protocol using the ECT-001-CB technology (UM171 molecule) has proven to be technically feasible and safe. UM171 expanded CB was associated with a median neutrophil recovery at day (D)+18 post transplant. Amongst 22 patients who received a single UM171 CB transplant with a median follow-up of 18 months, risk of TRM (5%) and grade 3-4 acute GVHD (10%) were low. There was no moderate-severe chronic GVHD. Thus, overall and progression free survival at 12 months were impressive at 90% and 74%, respectively. The UM171 expansion protocol allowed access to smaller, better HLA matched CBs as >80% of patients received a 6-7/8 HLA matched CB. Interestingly there were patients with high-risk hematologic malignancies and multiple comorbidities (5 patients who had already failed an allogeneic transplant and 5 patients with refractory/relapsed acute leukemia/aggressive lymphoma). Despite this high risk population, progression was 20% at 12 months.
This new study seeks to test a similar strategy in a group of patients with high risk acute leukemia/myelodysplasia.

Start Date13 Nov 2020

Sponsor / Collaborator

ExCellThera, Inc.

[+1]

100 Clinical Results associated with Stem cell therapeutics (ExCellThera)

100 Translational Medicine associated with Stem cell therapeutics (ExCellThera)

100 Patents (Medical) associated with Stem cell therapeutics (ExCellThera)

Literatures (Medical) associated with Stem cell therapeutics (ExCellThera)

01 May 2022·LeukemiaQ1 · MEDICINE

Human CD34+ very small embryonic-like stem cells can give rise to endothelial colony-forming cells with a multistep differentiation strategy using UM171 and nicotinamide acid

Q1 · MEDICINE

Letter

Author: Smadja, David M ; Ratajczak, Janina ; Domingues, Alison ; Rossi, Elisa ; Detriche, Grégoire ; Richez, Ulysse ; Blandinieres, Adeline ; Kucia, Magdalena ; Ratajczak, Mariusz Z ; Bujko, Kamila

Human CD34very small embryonic-like stem cells can give rise to endothelial colony-forming cells with a multistep differentiation strategy using UM171 and nicotinamide acid,.To develop a source of ECFC-like cells for vascular repair, the use of human induced pluripotent stem cells (iPS) and embryonic stem cells (ESCs) has been investigated.Therefore, VSELs could represent a clin. relevant alternative to iPS or ESCs, since they do not complete blastocyst development and do not form teratomas after transplantation into deficient mice.VSELs are the most primitive stem cells in bone marrow, which can give rise to different tissue committed progenitor cells from all germ layers without confounding factor of feeder cell fusion with VSELs.All in all, we demonstrate for the first time here a full in vitro differentiation of VSELs in true vasculogenic progenitor ECFCs with a chem. identified media with UM-171 and NMA added to culture from the first day of culture.Further studies need to better decipher origin of ECFCs and improve the vascular regenerative potential of VSELs by enhancing proliferative and vasculogenic potential of VSELECFCs in vitro and in vivo and obtain highly efficient production of patient-derived VSEL-ECFCs for the treatment of vascular disease.

01 Oct 1991·Zhonghua shen jing jing shen ke za zhi = Chinese journal of neurology and psychiatry

[Serum prolactin response to electroconvulsive therapy in patients with major depression].

Article

Author: Duan, Y

Serum prolactin (PRL) levels were determined at 30 min before and 5, 15, 30 and 60 min after the first and sixth electroconvulsive therapy (ECT-1 and ECT-6) in 12 female patients with major depression. There was a significant increase in serum PRL after ECT-1. The mean maximum PRL level was obtained at 30 min after ECT-1 and was 3.18 times of baseline level. The rate between mean maximum PRL level after and baseline before ECT-6 was 1.89 and was significantly lower than that during ECT-1. ECT-6 caused a significantly lower PRL release than did ECT-1 too. The possible mechanisms of produced these results were discussed.

News (Medical) associated with Stem cell therapeutics (ExCellThera)

26 Jun 2024

·www.globenewswire.com

ExCellThera Announces EMA’s Acceptance under Accelerated Assessment of Market Authorisation Application (MAA) for UM171 Cell Therapy for Patients with Hematological Malignancies who Lack a Readily Available Suitable Donor

- Market Authorisation Application (MAA) for UM171 Cell Therapy accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for adult patients with hematological malignancies requiring a stem cell transplant who lack a readily available suitable donor June 25, 2024 -- ExCellThera Inc. (ExCellThera), a world leader in enhanced blood stem cell expansion and therapies, announced today that the Market Authorisation Application (MAA) for UM171 Cell Therapy (INN-dorocubicel) has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for adult patients with hematological malignancies requiring a stem cell transplant who lack a readily available suitable donor. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted UM171 Cell Therapy accelerated assessment as it was deemed of major interest from a public health point of view. Accelerated assessment aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure and follows the EMA granting Orphan Medicinal Product designation and access to the Priority Medicines scheme (PRIME) in 2020. “We are excited that the EMA has accepted this regulatory submission under an accelerated assessment procedure, as UM171 Cell Therapy has immense potential to help address a high unmet medical need for patients with hematological malignancies who require a stem cell transplant but lack a readily available suitable donor,” said David Millette, CEO of ExCellThera. “We now look forward to working closely with the EMA in the coming months to bring this therapy to the patients who need it.” UM171 Cell Therapy (INN-dorocubicel), developed by Cordex Biologics, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients to treat hematologic malignancies in clinical trials in the United States, Europe and Canada. UM171 Cell Therapy has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA. UM171 Cell Therapy has successfully completed Phase 2 trials in patients with high and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with refractory or active disease, patients requiring a second transplant, and patients with TP53 mutations or other genetic abnormalities. The initiation of a Phase 3 trial in this patient population is planned for the second half of 2024. The use of UM171 Cell Therapy in other patient populations, including patients with multiple myeloma, pediatric patients, and patients with non-malignant hematological diseases, is also being explored. UM171 Cell Therapy is an investigational cell therapy, and its safety and efficacy have not been established by the FDA, EMA, Health Canada or any other health authority. ExCellThera is a world leader in enhanced blood stem cell expansion. ExCellThera’s proprietary EnhanceTM platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding HSCs from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the EnhanceTM platform, including the proprietary molecule UM171 which has a first- and best-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit excellthera.com, and follow us on LinkedIn. The content above comes from the network. if any infringement, please contact us to modify.

Cell TherapyOrphan DrugAccelerated Approval

02 Jan 2024

·www.biospace.com

ExCellThera to Conduct Investor Meetings During the J.P. Morgan 42nd Annual Healthcare Conference and to Participate in Upcoming Investor Conferences

MONTREAL, Jan. 02, 2024 (GLOBE NEWSWIRE) -- ExCellThera Inc. (ExCellThera), a world leader in blood stem cell therapies, announced today that its senior leaders will be holding investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8-11, 2024, in San Francisco, CA, and will be participating in the following investor conferences in January: 2024 Biotech Showcase (Presentation) Presentation Date and Time: January 8, 2024 at 4:45 PM PT Speaker: David Millette, Chief Executive Officer Location: San Francisco, CA, Ballroom Franciscan D, Hilton Union Square ExCellThera will also hold one-on-one investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8-11, 2024, in San Francisco, CA. To request a one-on-one meeting with ExCellThera, please contact sellinwood@kendallir.com. B Riley 4th Annual Oncology Conference (Fireside Chat) Presentation Date and Time: January 18, 2024 at 10:00 AM ET Speakers: Guy Sauvageau, Founder and Chief Scientific Officer and David Millette, Chief Executive Officer Location: Virtual About UM171 Cell Therapy UM171 Cell Therapy has been evaluated in over 100 patients to treat hematologic malignancies in clinical trials in the United States, Europe and Canada. UM171 Cell Therapy has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designation from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA. High Unmet Medical Need UM171 Cell Therapy Patients with high and very high-risk acute leukemias and myelodysplasias, including patients with refractory or active disease, patients requiring a second transplant, and patients with TP53 mutations or other genetic abnormalities, have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care. UM171 Cell Therapy has successfully completed Phase 2 trials in high and very high-risk acute leukemias and myelodysplasias. A Phase 3 trial is planned in 2024 for UM171 Cell Therapy for the treatment of high and very high-risk acute leukemias and myelodysplasias. Patients with hematological malignancies requiring a stem cell transplant who lack a readily available suitable donor, including familial, unrelated or haploidentical donor, or cord blood of sufficient quantity. A Market Authorization Application (MAA) submission was completed and is under accelerated assessment with the European Medicines Agency (EMA) for the licensure of UM171 Cell Therapy for adult patients with hematological malignancies requiring a stem cell transplant who lack a readily available suitable donor. The use of UM171 Cell Therapy in other patient populations, including pediatric patients and patients with non-malignant hematological diseases, is also being explored. UM171 Cell Therapy is an investigational cell therapy, and its safety and efficacy have not been established by the FDA, EMA, Health Canada or any other health authority. About ExCellThera and UM171 Technology ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera’s proprietary EnhanceTM platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding HSCs from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the EnhanceTM platform, including the proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit excellthera.com, and follow us on LinkedIn. Investor and Media Contact Sarah Ellinwood Kendall Investor Relations sellinwood@kendallir.com

Cell TherapyOrphan DrugPhase 2Phase 3

12 Dec 2023

·www.globenewswire.com

ExCellThera Announces Positive Phase 2 Study Results from UM171 Cell Therapy in Patients with High-risk Leukemias and Myelodysplasias at American Society of Hematology (ASH) 2023 Annual Meeting

- Data presented in an oral session at ASH 2023, building on strong data from prior Phase 1/2 trial and comparative registry studies - UM171 cell therapy achieved the primary endpoint of progression-free survival (63% at 2 years) in high and very high-risk cohort and demonstrated an excellent safety profile - Company plans to initiate a registrational Phase 3 trial in in high and very high-risk leukemias and myelodysplasias in 2024 MONTREAL, Dec. 12, 2023 (GLOBE NEWSWIRE) -- ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and metabolic fitness, announced today positive results from 50 patients in two multi-center Phase 2 trials for UM171 cell therapy conducted at transplant centers in the U.S., Canada and Europe, building on prior strong data from a Phase 1/2 trial and comparative registry studies (CIBMTR and EBMT). The data were presented for the first time in an oral session at the 65th American Society of Hematology Annual Meeting & Exposition (ASH) by Filippo Milano, M.D., Ph.D., Associate Professor, Translational Science and Therapeutics Division, Fred Hutchinson Cancer Center, and demonstrated excellent clinical outcomes at two years for this high and very high-risk cohort, including strong rates of overall survival (67%) and progression-free survival (63%), as well as low rates of non-relapse mortality (19%), relapse (18%) and moderate-to-severe chronic GVHD (7%). “There is an unmet need for new treatment options for patients with high and very high-risk leukemias and myelodysplasias who have low survival outcomes and high incidence of relapse,” said Filippo Milano, M.D., Ph.D., Director of Fred Hutch’s Cord Blood Transplant Program. “In these UM171 Phase 2 studies, about 70% of patients survived two years post-transplant without evidence of disease recurrence. These outcomes are encouraging considering that 30% of the enrolled patients did not benefit from previous stem cell transplantation. In addition, 20% of the study population had an identified TP53 genetic mutation, which has been associated with particularly dismal outcomes.” “Patients in high-risk categories, including those with refractory or active disease, with genetic abnormalities, or who have relapsed after a first transplant, have limited treatment options under the current standard of care,” said David Millette, Chief Executive Officer of ExCellThera. “We are very excited to share the positive Phase 2 results for UM171 cell therapy, building on strong data from our Phase 1/2 trial and comparative registry studies. We believe this establishes UM171 cell therapy as a potential treatment options for high-risk leukemias and myelodysplasias based on its combined efficacy and safety profile. Based on these highly compelling data, we are looking forward to advancing UM171 cell therapy forward to a registrational Phase 3 trial in high and very high-risk leukemias and myelodysplasias in 2024.” About UM171 Cell Therapy UM171 cell therapy has been evaluated in over 100 patients to treat hematologic malignancies in clinical trials in the United States, Europe and Canada. UM171 cell therapy has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designation from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA. UM171 cell therapy has successfully completed Phase 2 trials in high and very high-risk acute leukemias and myelodysplasias, and a Phase 3 trial is expected as soon as possible. Patients with high and very high-risk acute leukemias and myelodysplasias, including patients with refractory or active disease, patients requiring a second transplant, and patients with TP53 mutations or other genetic abnormalities, have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care. The use of UM171 cell therapy in other patient populations, including patients unable to find a stem cell donor, pediatric patients and patients with non-malignant hematological diseases, is also being explored. UM171 cell therapy is an investigational cell therapy, and its safety and efficacy have not been established by the FDA, EMA, Health Canada or any other health authority. About ExCellThera ExCellThera is a world leader in blood stem cell expansion and metabolic fitness. ExCellThera’s proprietary Enhance™ platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding HSCs from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with bio-pharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the EnhanceTM platform, including proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit excellthera.com, and follow us on LinkedIn.

Clinical ResultPhase 2Cell TherapyASHOrphan Drug

100 Deals associated with Stem cell therapeutics (ExCellThera)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	NDA/BLA	European Union	ExCellThera, Inc.	25 Jun 2024
Myeloid Tumor	Phase 2	United States	ExCellThera, Inc.	01 Dec 2021
Myelodysplastic Syndromes	Phase 2	Canada	ExCellThera, Inc.	01 Apr 2019
Refractory Acute Leukemia	Phase 2	Canada	ExCellThera, Inc.	01 Apr 2019
Plasma Cell Leukemia	Phase 2	Canada	ExCellThera, Inc.	07 Mar 2018
Acute Chest Syndrome	Phase 1	United States	ExCellThera, Inc.	13 Jul 2021
Hematopoietic stem cell transplantation	Discovery	European Union	ExCellThera, Inc.	16 Dec 2020
Graft vs Host Disease	Discovery	United States	ExCellThera, Inc.	13 Dec 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04103879 \| NCT03913026 (GlobeNewswire) Manual	Phase 2	Leukemia \| Myelodysplastic Syndromes	50	UM171	zjgjswkzxq(mreofonhmh) = sulpuyumch cbqsqjtduf (wcvjdrnsga ) View more	Positive	12 Dec 2023
ASGCT2023	Not Applicable	Anemia, Sickle Cell CD34+ \| CD38- \| CD45RA ... View more	-	UM171	cjihvyrfny(xpiazmevhn) = ujueptkalv mokdjscdhf (gslgueojwv ) View more	Positive	01 May 2023
ASGCT2023	Not Applicable	Anemia, Sickle Cell CD34+ \| CD38- \| CD45RA ... View more	-	UM171 (Control)	wqlgwwglqr(sfzgjukvho) = swzpqfgtni zilssbedeg (tyumgkeazn )	Positive	01 May 2023
Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	Bone Marrow Neoplasms	-	UM171 (Expanded Cord Blood Grafts)	qpkptoqxlz(hmujphzdqg) = odeylcsiqi zlsuhikyyi (wdisyhlgto ) View more	-	01 Feb 2023
Tandem Meetings ASTCT and CIBMTR2020	Phase 1	Hematopoietic stem cell transplantation	22	UM171 (Myeloablative conditioning regimen + single CB transplant)	zofcpjsnbq(oiqnirnlsg) = gbjczeqpkw lorngfnknh (gispdbznch ) View more	Positive	01 Mar 2020
ASGCT2019	Not Applicable	-	-	UM171	mdpmcdsbja(tkgzvgquvg) = qjkhoczjuy qhegtmxrki (aootzmzehg )	-	22 Apr 2019
Tandem Meetings ASTCT and CIBMTR2018	Not Applicable	-	17	UM171 expanded cord blood (eCB)	jhxltbjndr(tqumgucgbs) = thpuvkbvel ehxmervgyy (lzqjacnrfe ) View more	Positive	01 Mar 2018
Tandem Meetings ASTCT and CIBMTR2018	Not Applicable	-	17	UM171 (Peripheral blood or marrow)	jhxltbjndr(tqumgucgbs) = hwfuglejps ehxmervgyy (lzqjacnrfe )	Positive	01 Mar 2018
ASGCT2014	Not Applicable	-	-	UM171	cjciaykqiz(zsnrygevbi) = wspqpgggsj mcclcgjpqe (jndumjposi ) View more	-	01 May 2014
ASGCT2014	Not Applicable	-	-	UM171 (SR1)	cjciaykqiz(zsnrygevbi) = ojsumxzzdh mcclcgjpqe (jndumjposi ) View more	-	01 May 2014

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Stem cell therapeutics (ExCellThera)

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