NCT06087848 A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events
| NCT ID | NCT06087848 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Cellcolabs Clinical LTD. |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-07 |
| Primary Completion | 2029-10-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2023-10-07 with a primary completion date of 2029-10-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06087848 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 85 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06087848 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06087848 currently recruiting?
Yes, NCT06087848 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cellcolabs Clinical LTD. to inquire about joining.
Where is the NCT06087848 trial being conducted?
This trial is being conducted at Nassau, The Bahamas.
Who is sponsoring the NCT06087848 clinical trial?
NCT06087848 is sponsored by Cellcolabs Clinical LTD.. The trial plans to enroll 100 participants.