A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I/IIa Clinical Study of Cellcolabs' Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty

MROS/220622/INDTP

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

2025-01-01

2026-01-01

2027-01-10

Not yet recruiting

Early phase I

12

Inclusion Criteria: * 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 * Have a serum TNF-alpha level \>2.5 pg/m Exclusion Criteria: 1. Unwilling or unable to perform any of the assessments required by the protocol 2. 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 3. Have a score of 24 or lower on the Mini Mental State Examination (MMSE) 4. Have poorly controlled blood glucose levels (HbA1c \>8.0%). 5. Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma. 6. Have any condition that limits lifespan to \< 1 year according to the Principal Investigator's discretion 7. Have autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus). 8. Undergoes chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-alpha antagonists (prednisone use at doses of \< 5 mg daily is allowed) 9. Hepatitis B virus positive 10. Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive 11. Have a resting blood oxygen saturation of \<93% (measured by pulse oximetry). 12. Known or suspected alcohol or drug abuse within three years preceding Screening 13. Have a known hypersensitivity to dimethyl sulfoxide (DMSO). 14. An organ transplant recipient (other than transplantation for corneal). 15. Actively listed (or expected future listing) for transplant of any organ (other than corneal transplant). 16. Have any clinically important abnormal screening laboratory values, including, but not limited to: i. Haemoglobin \<10.0 g/dL, ii. White blood cell \<2,500/ul, or platelet count \<100,000/ul iii. Liver dysfunction evidenced by enzymes (AST and ALT) \> 3 times the upper limit of normal (ULN) 17. Coagulopathy with an international normalized ratio (INR) \>1.3 is not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors). 18. Uncontrolled hypertension (resting systolic blood pressure \>180 mm Hg or diastolic blood pressure of \> 110 mm Hg at screening) 19. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 3 months. 20. Have congestive heart failure defined by New York Heart Association (NYHA) Class III or IV, or an ejection fraction of \<25%. 21. Have a coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous 3 months 22. Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), and/or PaO2 levels \<60 mmHg. 23. Have a partial ileal gastric bypass or other significant intestinal malabsorption. 24. Have advanced liver or renal disease 25. Have cognitive or language barriers that prohibit obtaining informed consent or any study elements. 26. Currently hospitalized or living in an assisted living facility or a long-term care facility. 27. Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial. 28. Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study

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2024-04-18