Trials / Terminated
TerminatedNCT02585622
NEPHSTROM for Diabetic Kidney Disease
Novel Stromal Cell Therapy for Diabetic Kidney Disease (NEPHSTROM Study)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Mario Negri Institute for Pharmacological Research · Academic / Other
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Mesenchymal Stromal Cells | Cells will be administered intravenously at 3 different doses (80, 160, or 240 x 10\^6, fixed dose) over 10-20 minutes. Volume total of fluid infused: 40 ml |
| OTHER | Placebo | Volume total of fluid infused: 40 ml |
Timeline
- Start date
- 2017-12-11
- Primary completion
- 2022-11-03
- Completion
- 2024-01-03
- First posted
- 2015-10-23
- Last updated
- 2024-11-29
Locations
4 sites across 3 countries: Ireland, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT02585622. Inclusion in this directory is not an endorsement.