Evaluating the effects of a stem cell product on heart disease prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Live Well
  Nassau, The Bahamas, The Bahamas Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Abnormal menstrual bleeding in women on antithrombotic drugs after heart surgery

  This study looks at whether women on blood thinners after heart surgery have abnormal menstrual bleeding and what factors might put some at higher risk.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07870941

• AI-powered ECG to help diagnose and predict outcomes in heart disease

  Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07856472

• Colchicine for preventing cardiovascular disease in adults with type 2 diabetes

  A 24-week study will test whether low-dose colchicine can help protect blood vessels in adults with type 2 diabetes who have not yet developed artery disease, compared with a placebo.

  Recruiting Phase 2 Tan Tock Seng Hospital · Singapore, Singapore · NCT07837934

• Optimised Cardio-Renal Care for CKD and heart disease

  This study tests whether a specialised Cardio-Renal Clinic can improve heart and kidney health and quality of life for adults with chronic kidney disease and cardiovascular disease.

  Recruiting Odense University Hospital · Svendborg · NCT07835828

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

• One-stop photon-counting CT for patients after PCI

  This study tests a single CT exam using photon-counting technology to image the heart after stent placement in people who have had PCI.

  Recruiting Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07763340

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.