Nephstrom (V1.1 07/03/2017)
Research type
Research Study
Full title
Novel Stromal Cell Therapy for Diabetic Kidney Disease
IRAS ID
219066
Contact name
Paul Cockwell
Contact email
Sponsor organisation
IRCCS ‐ Istituto di Ricerche Farmacologiche Mario Negri
Eudract number
2016-000661-23
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT02585622, US NCT
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study is a randomized double blind placebo controlled study of cell therapy, given as Mesenchymal Stromal Cells (MSCs), in patients with diabetic kidney disease. Diabetic kidney disease (DKD) is a very common cause of end stage renal failure (kidney failure requiring dialysis or transplantation) and has a major impact on the health of those affected.
Participants will be eligible for the study if they have progressive DKD, that is deteriorating kidney function and evidence of a high risk of further deterioration of kidney function.
Forty eight (48) participants will be randomly allocated in a ratio of 3:1 to receive an infusion of MSCs or placebo. The study will use a dose escalation design with infusion of one of three doses of the MSC product (called NEPHSTROM ORBCEL-M) at 80, 160 or 240 x1000000 cells.
Each of the 3 dose groups will comprise 12 patients receiving a single infusion of one of the three doses and 4 patients receiving a placebo infusion. MSCs have been used worldwide in thousands of patients to date. This is the first time that this particular stem cell product has been used in this setting. The investigational MSC product will be derived from the bone marrow of unmatched healthy adult volunteer donors.
The study will be performed at four academic clinical centres in Ireland (1), Italy (1) and the UK (2). The trial will comply with the principles of ICH GCP, the standards set out by the EU Directive and the applicable regulatory requirements.
The duration of follow up after the trial intervention will be 18 months. The focus of the study will primarily be the safety, feasibility and tolerability of the study. Outcomes will also include the impact of the treatment on kidney function.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0347
Date of REC Opinion
17 Aug 2017
REC opinion
Further Information Favourable Opinion