A Longitudinal Open-Label Multi-center Single-Arm Phase I/IIa Study to Evaluate the Safety and Preventive Effect on Cardiovascular Events of Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product, StromaForte, in Study Participants.

2023-001-BHS

The goal of this phase I/II clinical trial is to evaluate the safety and preventive effect of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in study participants. 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) To evaluate the effects of Mesenchymal stem cells on Prevention of Cardiovascular Events by following the reported incidence of cardiovascular events amongst study participants up to five year post-injection 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

2023-10-07

2029-10-06

2029-10-06

Recruiting

Early phase I

100

Inclusion Criteria: 1. Willing and able to provide written informed consent and comply with all procedures required by the protocol. 2. Aged ≥ 25 to 85 years at the time of signing the informed consent form. 3. Subjects with pre-morbid or stable morbid medical conditions, not requiring significant changes to their current medical therapy for \> 6 months prior to enrolling in this study, are eligible Exclusion Criteria: 1. Unwilling or unable to perform any of the assessments required by the protocol. 2. Have end stage liver or renal disease. 3. Have a clinical history of malignancy within 2.5 years (i.e., study participants with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma. 4. Have any condition that limits lifespan to \< 1 year according to the Principal Investigator's discretion. 5. Hepatitis B virus positive 6. Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive 7. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months. 8. Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of \<25%. 9. Uncontrolled hypertension (resting systolic blood pressure \>220 mm Hg or diastolic blood pressure of \> 150 mm Hg at screening) 10. Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month. 11. Have acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), Have cognitive or language barriers that prohibit obtaining informed consent or any study elements. 12. Severe acute infection at time of screening and treatment with study drug 13. Pregnant or Breastfeeding 14. Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial. 15. 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 study participant's participation for the full duration of the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-04-19