The goal of this ongoing open-label, single-arm, phase I/IIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or/and degeneration. Any male or female with any musculoskeletal injury and/or degeneration above 18 years will be enrolledThe main questions it aims to answer are:
To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria
Change from baseline in subjective pain assessment in each injured and/or degenerated area (if multiple injury is reported, each area to be followed up separately)
Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered.
Willing and able to provide written informed consent and comply with all procedures required by the protocol.
Aged ≥ 18 years at the time of signing the informed consent form and has any diagnosed musculoskeletal injury and/or degenerative conditions.
Unwilling or unable to perform any of the assessments required by the protocol.
Have an injury that is expected to selfheal within 14 days without remaining sequel.
Have an injury for which there is solid scientific evidence that the study compound will have no effect.
Have traumatic head injury or skull, teeth or jaw injury as diagnosis for inclusion in trial.
Single group
Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte)
Biological/Vaccine50 x 106 allogeneic BM-derived MSCs formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under state of the art way of application that is ultrasound guidance which will ensure precise delivery of the BM derived MSCs at the site of injury or degeneration along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury or degeneration is not feasible.
To evaluate the safety of human allogenic BM derived MSCs in musculoskeletal injuries and/or degeneration for all patients either face to face or remotely.
To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment for all patients either face to face or remotely.
To evaluate the effect of MSC administration in reported resting pain and pain in movement/loading/weight bearing in each injured and/or degenerated area
To evaluate the effect of MSC administration in reported resting pain and pain in movement/loading/weight bearing in each injured and/or degenerated area (if multiple injuries is reported, each area to be followed up separately) from baseline to 28±10, 84±10, 168±10 and 349±10 days for all patients either face to face or remotely.
Change in Health-related quality of life according to Short-Form 36
Change in Health-related quality of life according to Short-Form 36 at 28±10, 84±10, 168±10 and 349±10 days post-injection for all patients either face to face or remotely. SF-36 scores range from 0 (worst) to 100 (best) (5).
Change in Health-related quality of life according to Patient Global Impression of Change
Change in Health-related quality of life according to Patient Global Impression of Change at 28±10, 84±10, 168±10 and 349±10 days post-injection for all patients either face to face or remotely. The PGIC scale goes from 1 - 7 with 1 being the best positive outcome and 7 the most negative outcome.
Change in pain assessment
Change from baseline in subjective pain assessment. Both resting pain and pain in movement/loading/weight bearing will be assessed according to the VRS questionnaire in pre-existing degenerative disorders, distinct from the condition being treated from the baseline to 28±10, 84±10, 168±10 and 349±10 days for all patients either face to face or remotely. The VRS score is measured 0 - 3 with 0 being no pain and 3 being the maximal pain.
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