NEPHSTROM for Diabetic Kidney Disease

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

• Diabetic Kidney Disease

Interventions

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

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• Papa Giovanni XXIII Hospital

  collaborator OTHER

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• Belfast Health and Social Care Trust

  collaborator OTHER

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• University Hospital Birmingham, NHS Foundation Trust, Hospital, Birmingham, UK

  collaborator UNKNOWN

• NHS Blood and Transplant

  collaborator OTHER_GOV

• Mario Negri Institute for Pharmacological Research

  lead OTHER

Principal Investigators

• Giuseppe Remuzzi, MD · ASST Papa Giovanni XXIII, Bergamo, Italy/IRCCS - Mario Negri Institute for Pharmacological Research

• Mattew Griffin, MD · National University of ireland - Galway University Hospital -Regenerative Medicine Institute

• Paul Cockwell, MD · University Hospital Birmingham NHS Foundation Trust

• Peter Maxwell, MD · Belfast Health and Social Care Trust - Belfast City Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-11

Primary Completion

2022-11-03

Completion

2024-01-03

Countries

• Ireland
• Italy
• United Kingdom

Study Locations