The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty. The main questions it aims to answer are:
To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE)
Observe the change in inflammatory markers from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.)
Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min
Willing and able to provide written informed consent and comply with all procedures required by the protocol
Aged > 60 and < 85 years at the time of signing the informed consent form
Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale score of 5 "mildly frail" or 6 "moderately frail"
Have a 6-minute walk distance of > 200m and < 400 m
Unwilling or unable to perform any of the assessments required by the protocol
Have a diagnosis of any disabling neurologic disorder, including, but not limited to, Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (e.g., muscle weakness or gait disorder), or diagnosis of dementia
Have a score of 24 or lower on the Mini Mental State Examination (MMSE)
Have poorly controlled blood glucose levels (HbA1c >8.0%).
Single group
Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
Biological/Vaccine100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min
To evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product Stromaforte
To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events 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
Change in tumor necrosis factor α (TNF-α)
Change in tumor necrosis factor α TNF-α from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.)
Change in C Reactive Protein (CRP)
Change in C Reactive Protein (CRP) from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.
Change in Interleukin-6 (IL-6)
Change in Interleukin-6 (IL-6) from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.
Change in Complete Blood Count (CBC) in peripheral blood with differential
Change in Complete Blood Count (CBC) in peripheral blood with differential from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.
Change in the 6-minute walk test (6-MWT)
Change in the 6-minute walk test (6-MWT) from baseline to 28, 84 and 168 days post infusion
Change in hand grip strength (dynamometry)
Change in hand grip strength (dynamometry) from baseline to 84 and 168 days post-infusion
Change in EQ-5D-3L
Change in EQ-5D-3L from baseline to 84, and 168 days post-infusion
Change in Multidimensional Fatigue Inventory (MFI)
Change in Multidimensional Fatigue Inventory (MFI) from baseline to 84, and 168 days post-infusion
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