Status:
RECRUITING
A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events
Lead Sponsor:
Cellcolabs Clinical LTD.
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
25-85 years
Phase:
PHASE1
PHASE2
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 ...
Detailed Description
Cardiovascular disease (CVD) is a group of disorders of the heart and blood vessels including, among other coronary heart, cerebrovascular, and peripheral arterial diseases that are difficult to rever...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- Aged ≥ 25 to 85 years at the time of signing the informed consent form.
- 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
- Unwilling or unable to perform any of the assessments required by the protocol.
- Have end stage liver or renal disease.
- 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.
- Have any condition that limits lifespan to \< 1 year according to the Principal Investigator's discretion.
- Hepatitis B virus positive
- Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
- Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months.
- Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of \<25%.
- Uncontrolled hypertension (resting systolic blood pressure \>220 mm Hg or diastolic blood pressure of \> 150 mm Hg at screening)
- Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month.
- 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.
- Severe acute infection at time of screening and treatment with study drug
- Pregnant or Breastfeeding
- Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.
- 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.
Key Trial Info
Start Date :
October 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 6 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06087848
Start Date
October 7 2023
End Date
October 6 2029
Last Update
April 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Live Well
Nassau, The Bahamas, The Bahamas