Evaluating the effects of a stem cell product on heart disease prevention
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.
This study is testing whether a stem cell treatment can help prevent heart disease in people aged 25 to 85.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | All |
| Sponsor | Cellcolabs Clinical LTD. Industry-sponsored |
| Locations | 1 site (Nassau, The Bahamas) |
| Trial ID | NCT06087848 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and preventive effects of StromaForte, a human allogeneic bone-marrow-derived mesenchymal stromal cell product, administered via intravenous infusion. Participants aged 25 to 85 will receive 100 million stem cells to evaluate the incidence of cardiovascular events over a five-year period. The study will monitor adverse events and overall tolerability for 28 days post-injection, providing insights into the potential of stem cells in preventing cardiovascular diseases.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 25 to 85 with stable medical conditions who can provide informed consent.
Not a fit: Patients with end-stage liver or renal disease, recent malignancies, or significant life-limiting conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of cardiovascular events in at-risk populations.
How similar studies have performed: While the use of stem cells in cardiovascular disease is an emerging field, this specific approach with StromaForte is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nassau, The Bahamas
- Live Well — Nassau, The Bahamas, The Bahamas (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.