A Phase 2/3, Prospective, Randomized, Multi-center, Open-Label, Controlled Trial to Assess the Efficacy & Safety of Cellular Immunotherapy With MDR-102 for Induction of Immune Quiescence™in Recipients of HLA-mismatched, LD Kidney Transplants

The Phase 2 primary objective is to evaluate achievement of persistent mixed chimerism and withdrawal of at least one immunosuppression drug for a minimum of 6 months with no episodes of biopsy-proven acute rejection or transplant kidney loss induced by cellular immunotherapy with MDR-102 in recipients of 1, 2, or 3 out of 6 human leukocyte antigen (HLA)-mismatched, living donor kidney transplants.
The Phase 3 primary objective is to evaluate achievement of induction of immune quiescence by cellular immunotherapy with MDR-102 in recipients of 1, 2, or 3 out of 6 HLA-mismatched, living donor kidney transplants. Immune quiescence is defined as remaining on maintenance immunosuppression monotherapy with Tac or CsA for 12 months or more after completion of anti-rejection immunosuppression drug therapy reduction with no episodes of biopsy-proven acute rejection, transplant kidney loss, or subject deat.

Start Date01 Dec 2024

Sponsor / Collaborator

Medeor Therapeutics, Inc.

100 Clinical Results associated with MDR-102

100 Translational Medicine associated with MDR-102

100 Patents (Medical) associated with MDR-102

Literatures (Medical) associated with MDR-102

01 May 2023·International Journal of Pharmaceutics

Bio-adhesive and ROS-scavenging hydrogel microspheres for targeted ulcerative colitis therapy

Article

Author: Chen, Jun ; He, Ziyun ; Sun, Qiqi ; Zhao, Quan ; He, Bin ; Pu, Yuji ; Tang, Lei

Ulcerative colitis (UC) as an important type of inflammatory bowel disease is a chronic disease characterized by intestinal dyshomeostasis. The UC treatment is challenged by the insufficiency of drug delivery and retention. Herein, we fabricated an intrarectal formulation of olsalazine (Olsa)-loaded hydrogel microspheres (LDKT/Olsa) with good bio-adhesiveness and reactive oxygen species (ROS)-scavenging ability to enhance drug retention and therapeutic effect. Low methoxy pectin-dopamine conjugate/konjac glucomannan composite hydrogel microspheres (LDKT) with a size ranging from 10 to 100 μm were prepared by using Zn²⁺ and ROS-sensitive thioketal as crosslinkers. Upon intrarectal administration, the negatively charged and dopamine-functionalized hydrogel microspheres efficiently adhered to cationic surface of inflammatory mucosa, scavenging ROS and releasing Zn²⁺ and Olsa for antibacterial and anti-inflammatory effects. In the dextran sodium sulfate (DSS)-induced mouse UC model, the microspheres significantly reduced the levels of colonic ROS and pro-inflammatory cytokines, improved gut mucosal barrier integrity, and remarkably relieved colitis. Overall, the LDKT microspheres are promising carriers to deliver drugs for UC treatment.

30 Sep 2022·Korean Journal of Transplantation

The significance of the first living donor kidney transplantation in Jeju: a case report

Author: Chang, Won-Bae ; Lee, Taeseung ; Shin, Young-Heun

To overcome the shortage of kidney donors, diverse methods have been utilized, including living donor kidney transplantation (LDKT) and extended criteria for deceased donor grafts. Currently, LDKT is a major treatment option. However, in Jeju, deceased donor kidney transplantation (DDKT) has been restricted due to the prolonged cold ischemia time (CIT) caused by the island's geographic disadvantages and transportation limitations. We report the first LDKT in Jeju, which demonstrates a means of overcoming prolonged CIT. A 67-year-old male patient with diabetic nephropathy underwent a preemptive ABO compatible LDKT (ABO type O+) from his 62-year-old wife. The operation was uneventful, using anti-thymocyte globulin based on the recipient's medical and immunologic risks. The patient recovered without significant complications and was discharged on postoperative day 15. Follow-up Doppler ultrasonography showed good blood flow to the kidney, and his serum creatinine levels steadily decreased and remained stable. The first successful LDKT in Jeju was significant in that kidney transplantation was implemented by compensating for its geographic limitations. In addition, we review machine perfusion as another method of avoiding prolonged CIT.

01 Mar 2022·Transplantation ProceedingsQ4 · MEDICINE

Clinical Significance of De Novo Donor Specific Antibody Based on the Type of Kidney Transplantation

Q4 · MEDICINE

Article

Author: Park, Woo Yeong ; Paek, Jin Hyuk ; Kim, Yaerim ; Jin, Kyubok ; Han, Seungyeup

BACKGROUNDPreemptive living donor kidney transplantation (P-LDKT) has shown a better prognosis than nonpreemptive living donor KT (NP-LDKT) or deceased donor KT (DDKT). However, association between KT type and de novo donor specific antibody (dnDSA) is uncertain.MATERIALSWe retrospectively analyzed 1114 patients who underwent KT between 1994 and 2020. We investigated the clinical significance of dnDSA based on KT type.RESULTSMean follow-up duration was 131.5 ± 89.5 months. Mean age of recipients, mismatched number of human leukocyte antigens and incidence of delayed graft function were significantly higher in DDKT group than P-LDKT and NP-LDKT groups. There were no significant differences of incidence of dnDSA and acute rejection within 1 year among them. Death-censored graft survival rate was significantly lower in all groups with dnDSA than without dnDSA, respectively. In positive dnDSA, NP-LDKT and DDKT groups tended to be lower in the death-censored graft survival compared to P-LDKT and there was a significant interaction between type of KT and dnDSA (P = .010). Independent risk factors were acute rejection within 1 year (hazard ratio [HR], 4.341; 95% CI, 1.758-10.720; P = .001), dnDSA positivity (HR, 3.170; 95% CI, 1.364-7.371; P = .007), and eGFR at 12 months after KT (HR, 3.701; 95% CI 2.049-6.686; P < .001).CONCLUSIONSThere was no significant difference of incidence of dnDSA based on KT type, but allograft survival was poor in all recipients with dnDSA. NP-LDKT and DDKT with dnDSA showed poor prognosis compared to P-LDKT with dnDSA. Therefore, continuous and rigorous surveillance of DSA needs among NP-LDKT and DDKT.

100 Deals associated with MDR-102

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Indication	Highest Phase	Country/Location	Organization	Date
Renal transplant rejection	Phase 3	-	Medeor Therapeutics, Inc.	01 Dec 2024
Renal transplant rejection	Phase 3	-	Medeor Therapeutics, Inc.	01 Dec 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2019	Not Applicable	Genetic Diseases, Inborn	-	Haplo-SCT with PT-Cy	cflhjlxymh(bmpylxphlj) = twsqjzemyd rxzteqabwi (pupihulbux ) View more	-	14 Jun 2019
				HLA matched donor transplantation	cflhjlxymh(bmpylxphlj) = vuntbrrtan rxzteqabwi (pupihulbux ) View more

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