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autologous bone marrow-derived mesenchymal stem cells (Royan Institute)
- Development stage
- Unknown
- Lead developer
- Royan Institute
- Modality
- Stem Cell Therapies → Cell Therapies
- Administration
- Intravenous
01
Overview
This investigational cell therapy, developed by the Royan Institute in Tehran, Iran, utilizes autologous bone marrow-derived mesenchymal stem cells (MSCs) for the treatment of newly diagnosed type 1 diabetes mellitus (T1D). The therapy involves harvesting MSCs from the patient's own bone marrow (iliac crest), expanding them to passages 2-3 under good manufacturing practice (GMP) conditions, and administering them via intravenous injection. The primary mechanism of action is systemic immunomodulation, aimed at suppressing the autoimmune destruction of insulin-producing pancreatic beta cells and potentially facilitating islet regeneration. A Phase I/II clinical trial conducted between 2015 and 2020 evaluated the safety and efficacy of this approach in preserving C-peptide levels and improving glycemic control in new-onset T1D patients.
- Other names
- autologous bone marrow-derived mesenchymal stem cellsRoyan Institute MSC therapyautologous bone marrow-derived MSCs
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