Safety and Effectiveness Study of StromaForte, a Human Bone-Marrow Derived Stem Cell Treatment, for Adults with Musculoskeletal Injuries or Degeneration

What this Trial Is About

Musculoskeletal disorders and injuries cause significant disability worldwide, affecting people of all ages and leading to pain, limited mobility, and reduced quality of life. This ongoing open-label, single-arm phase IIIa study is evaluating the safety of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte in patients with musculoskeletal injuries andor degeneration. The study aims to assess safety and changes in pain over one year after treatment with these stem cells. Participants receive 50 million StromaForte cells locally injected under ultrasound guidance at the injury or degeneration site, combined with or without 100 million cells given intravenously over about 30 minutes. If local injection is not possible, only the systemic intravenous treatment is given. Additional doses may be administered with specified minimum intervals between local and systemic doses. Four subgroups based on connective tissue injury or degeneration type are included. During the study, patients are monitored for adverse events up to one year after treatment. Researchers assess pain levels in each injured or degenerated area, quality of life measures using questionnaires, and changes in pain between treatment subgroups. Follow-up can be face-to-face or remote. This comprehensive evaluation will provide data on safety and patient-reported outcomes following StromaForte administration for musculoskeletal conditions.

A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration