Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes

Summary

To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes.

Timeline

Start

2017-11-28

Primary completion

2020-07-01

Completion

2020-09-04

Outcome

Met primary endpoint

paper C-peptide levels in placebo-treated individuals declined by 47%, whereas those in ProTrans-treated individuals declined by only 10% (p<0.05). PMID 37221247 ↗

release “ProTrans-2 . A since 2020 completed placebo-controlled Phase-2study in 15 type-1 diabetes patients showed significant treatment efficacy (p<0.05),” nextcellpharma.com ↗

release “placebo-controlled phase II study ProTrans-2 have retained significantly higher endogenous insulin production than patients who received placebo.” nextcellpharma.com ↗

release “randomized, placebo-controlled phase II trial ProTrans-2 have significantly maintained higher endogenous insulin production than patients who received placebo.” nextcellpharma.com ↗

Publications

• Carlsson PO, Espes D, Sisay S, Davies LC, Smith CIE, Svahn MG. Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial. Diabetologia. 2023 Aug;66(8):1431-1441. doi: 10.1007/s00125-023-05934-3. Epub 2023 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ProTrans	Cell therapy	2e+08 cells	Intravenous

Indications