Actively Recruiting
A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events
Led by Cellcolabs Clinical LTD. · Updated on 2024-04-19
100
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with all study procedures
- Aged 25 to 85 years at the time of consent
- Have pre-existing or stable medical conditions with no significant changes to treatment for over 6 months before enrolling
You will not qualify if you...
- Unwilling or unable to complete study assessments
- Have end stage liver or kidney disease
- History of cancer within 2.5 years, except treated basal cell carcinoma, melanoma in situ, or cervical carcinoma
- Have a condition limiting lifespan to less than 1 year
- Positive for Hepatitis B virus
- Positive for active Hepatitis C virus, HIV-1/2, or syphilis
- Unstable angina or severe peripheral artery disease in the past 2 months
- Congestive heart failure classified as NYHA Class IV or ejection fraction below 25%
- Uncontrolled high blood pressure (systolic >220 mm Hg or diastolic >150 mm Hg) at screening
- Recent coronary artery bypass, angioplasty, peripheral vascular surgery, or heart attack within 1 month
- Severe chronic obstructive lung disease stage III or IV
- Cognitive or language barriers preventing informed consent or study participation
- Severe acute infection at screening or treatment
- Pregnant or breastfeeding
- Participation in another investigational study within 30 days prior to consent
- Any condition, treatment, or laboratory abnormality that may affect study results or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Live Well
Nassau, The Bahamas, The Bahamas
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here