A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events

NCT06087848 | Recruiting Phase 1 DMC

• 1 other identifier: 2023-001-BHS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• To evaluate the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) of intravenous infusion of human allogeneic BM-derived MSCs product StromaForte for all study participants.

  To assess the safety of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment.

  28 day post-infusion

Secondary Outcomes (1)

• To evaluate the effects of MSCs on Prevention of Cardiovascular Events

  From baseline to 5 years

Other Outcomes (12)

• Incidence of Diabetes

  From baseline to 5 years

• Incidence of Arthritis

  From baseline to 5 years

• Changes in Blood Glucose levels

  From baseline to 5 years

Study Arms (1)

MSC Intervention Group

EXPERIMENTAL

Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cells in one intravenous infusion. Additional systemic treatments can be repeated after a minimum of 3 months and data will be collected to investigate the potential preventive benefits it provides for the above indications. Additional doses are optional for all study participants enrolled in the study and will be managed in a separate consenting process. Study participants opting for an extra dose must at the time of the extra dose meet the same inclusion and exclusion criteria as participants being included for the first dose

Biological: Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)

Interventions

Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte) BIOLOGICAL

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 in approximately 30 min

MSC Intervention Group

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellcolabs Clinical LTD.: lead

Study Sites (1)

Live Well

Nassau, The Bahamas, The Bahamas

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 18, 2023
• Study Start: October 7, 2023
• Primary Completion (Estimated): October 6, 2029
• Study Completion (Estimated): October 6, 2029
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

TH (1)