Mesenchymal stem cell transplantation in newly diagnosed type 1 diabetes patients: a phase I/II randomized placebo-controlled clinical trial

Who conducted the study and which universities were involved

The main work was carried out at the Royan Institute for Stem Cell Biology and Technology (ACECR), Tehran, Iran—a major Iranian center for stem cell research and regenerative medicine.

Researchers from Tehran University of Medical Sciences, Iran University of Medical Sciences, and the University of Science and Culture also participated. Among the lead researchers were Ensiyeh Hajizadeh-Saffar and Hossein Baharvand.

What They Studied

The researchers investigated the transplantation of autologous mesenchymal stromal/stem cells (MSCs) in patients with newly diagnosed type 1 diabetes. MSCs were compared with a placebo to assess the safety and potential impact of the therapy on disease control.

They assessed HbA1c, C-peptide, glucose levels, external insulin requirements, the frequency of hypoglycemia, and quality of life. In addition, immunological markers—IL-4, IL-10, IL-6, TNF- α, TGF-β1, and regulatory T cells—were investigated; that is, the authors were also interested in the potential immunomodulatory effects of MSCs.

Journal: Stem Cell Research & Therapy
Year: 2022
Type: Phase I/II randomized placebo-controlled clinical trial.