drugset / Trial / NCT02585622
NEPHSTROM for Diabetic Kidney Disease
Phase 1/2
Terminated
29 enrolled
Mario Negri Institute for Pharmacological Research
Belfast Health and Social Care Trust · collabIstituto Di Ricerche Farmacologiche Mario Negri · collabLeiden University Medical Center · collabNHS Blood and Transplant · collabNational University of Ireland, Galway, Ireland · collabPapa Giovanni XXIII Hospital · collabUniversity Hospital Birmingham NHS Foundation Trust · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and progressive diabetic kidney disease (DKD).
Timeline
- Start
- 2017-12-11
- Primary completion
- 2022-11-03
- Completion
- 2024-01-03
Outcome
Outcome not reported
Stopped (Enrollment): “IMP NEPHSTROM ORBECEL-M is expired and additional extension is not feasible. Low recruitment rate at Birmingham center.”
Publications
- Results Perico N, Remuzzi G, Griffin MD, Cockwell P, Maxwell AP, Casiraghi F, Rubis N, Peracchi T, Villa A, Todeschini M, Carrara F, Magee BA, Ruggenenti PL, Rota S, Cappelletti L, McInerney V, Griffin TP, Islam MN, Introna M, Pedrini O, Golay J, Finnerty AA, Smythe J, Fibbe WE, Elliman SJ, O'Brien T; NEPHSTROM Trial Consortium. Safety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM). J Am Soc Nephrol. 2023 Oct 1;34(10):1733-1751. doi: 10.1681/ASN.0000000000000189. Epub 2023 Aug 10.
- Lu B, Lerman LO. MSC therapy for diabetic kidney disease and nephrotic syndrome. Nat Rev Nephrol. 2023 Dec;19(12):754-755. doi: 10.1038/s41581-023-00776-z. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ORBCEL-M | Cell therapy | 8e+07 cells | Intravenous |
| Subject | ORBCEL-M | Cell therapy | 1.6e+08 cells | Intravenous |
| Subject | ORBCEL-M | Cell therapy | 2.4e+08 cells | Intravenous |