NCT01576328

A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin

Completed Phase 1/Phase 2 Last updated 1 June 2020

What this trial tests

Phase 1/Phase 2 trial testing Mesenchymal Precursor Cells (MPCs) in Type 2 Diabetes in 61 participants. Completed in 1 October 2015.

Timeline

1 April 2012

Primary endpoint
1 October 2013

1 October 2015

Quick facts

Lead sponsor	Mesoblast, Ltd.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	61
Start date	1 April 2012
Primary completion	1 October 2013
Estimated completion	1 October 2015
Sites	18 locations across United States

Drugs / interventions tested

• Mesenchymal Precursor Cells (MPCs) — full drug profile →
• Mesenchymal Precursor Cells (MPCs) — full drug profile →
• Mesenchymal Precursor Cells (MPCs) — full drug profile →

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Mesoblast, Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Primary objective of the study is to assess the safety and tolerability of MPC therapy
  Time frame: 116 Weeks
  Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmona

Sponsor's own description

This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trends in mesenchymal stem cell clinical trials 2004-2018: Is efficacy optimal in a narrow dose range?
   Kabat M, Bobkov I, Kumar S, Grumet M. · · 2020 · cited 337× · PMID 31804767 · DOI 10.1002/sctm.19-0202
2. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study.
   Skyler JS, Fonseca VA, Segal KR, Rosenstock J, et al · · 2015 · cited 90× · PMID 26153271 · DOI 10.2337/dc14-2830
3. Stem Cell-Based Clinical Trials for Diabetes Mellitus.
   de Klerk E, Hebrok M. · · 2021 · cited 78× · PMID 33716982 · DOI 10.3389/fendo.2021.631463
4. A review of clinical trials: mesenchymal stem cell transplant therapy in type 1 and type 2 diabetes mellitus.
   Cho J, D'Antuono M, Glicksman M, Wang J, et al · · 2018 · cited 78× · PMID 30510843
5. Alloreactive Immune Response Associated to Human Mesenchymal Stromal Cells Treatment: A Systematic Review.
   Sanabria-de la Torre R, Quiñones-Vico MI, Fernández-González A, Sánchez-Díaz M, et al · · 2021 · cited 37× · PMID 34279481 · DOI 10.3390/jcm10132991
6. Pathogenic Role of Adipose Tissue-Derived Mesenchymal Stem Cells in Obesity and Obesity-Related Inflammatory Diseases.
   Pestel J, Blangero F, Eljaafari A. · · 2023 · cited 19× · PMID 36766689 · DOI 10.3390/cells12030348
7. Enhancing the Therapeutic Potential of Mesenchymal Stromal Cell-Based Therapies with an Anti-Fibrotic Agent for the Treatment of Chronic Kidney Disease.
   Li Y, Ricardo SD, Samuel CS. · · 2022 · cited 11× · PMID 35682717 · DOI 10.3390/ijms23116035
8. Mesenchymal Stem/Stromal Cells Therapy for Metabolic Syndrome: Potential Clinical Application?
   Huang X, Liu Y, Li Z, Lerman LO. · · 2023 · cited 4× · PMID 37407022 · DOI 10.1093/stmcls/sxad052