Blood vessel–forming stem cells in healthy South Asian and European adults

Circulating Vascular Regenerative Cell Exhaustion in Individuals Without Type 2 Diabetes Who Are of South Asian or European Origins

This study will test whether blood vessel–forming stem cells differ between healthy adults of South Asian and European backgrounds.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group (Academic / other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 5 sites (Markham, Ontario and 4 other locations)
• Trial ID: NCT06769347 on ClinicalTrials.gov

What this trial studies

This is an observational, two-arm cross-sectional study enrolling 60 healthy South Asian and 60 healthy European adults. Researchers will collect peripheral blood samples and isolate vascular regenerative cells for counting and laboratory characterization. The goal is to see whether features of vascular regenerative cell exhaustion (VRCE) are present in healthy South Asian people compared with healthy European people. Findings will be compared between the two groups to explore whether differences might help explain elevated cardiovascular risk in South Asian populations.

Who should consider this trial

Good fit: Healthy adults aged 18 or older who self-identify as South Asian or European, have no history of type 2 diabetes or cardiovascular events, and can provide informed consent are ideal candidates.

Not a fit: People with type 2 diabetes, prior cardiovascular events, or other major life-threatening illnesses are excluded and are unlikely to benefit from participation in this particular study.

Why it matters

Potential benefit: If differences are found, this could point to a biological reason for higher cardiovascular risk in South Asians and help guide earlier prevention or new targeted treatments.

How similar studies have performed: Previous studies have reported vascular regenerative cell exhaustion in South Asian adults with diabetes or CVD, but applying the same blood-cell comparisons to healthy individuals is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Adults 18 years of age or older of South Asian origin or European origin as defined by the following: i. South Asian defined as any individual who identifies as Anglo-Indian, Bangladeshi, Bengali, Bhutanese, Goan, Gujarati, Indian, Jatt, Kashmiri, Maharashtrian, Malayali, Nepali, Pakistani, Punjabi, Sindhi, Sinhalese, Sri Lankan, Tamil, Telugu, or other South Asian origins. ii. European Origin defined as any individual who identifies as from western Europe, northern Europe, southern Europe, eastern Europe or other European origins.
2. Willing and able to provide written informed consent and comply with study requirements
3. Must fulfill the following exclusion criteria:

Exclusion Criteria:

1. No previous diagnosis of type 2 diabetes
2. Any previous CV events such as:

   1. Prior myocardial infarction
   2. Coronary revascularization
   3. Coronary artery disease, peripheral artery disease, cerebrovascular disease
3. Any life-threatening disease expected to result in death within the next 2 years
4. Any malignancy not considered cured (except basal cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
5. Known severe liver disease (e.g. Non-alcoholic fatty liver disease, chronic liver disease, liver cirrhosis, etc.)
6. White blood cell count ≥ 15 x 10\^9/L
7. Active infectious disease requiring antibiotic or anti-viral agents
8. Known acquired immunodeficiency syndrome such as HIV
9. On oral steroid therapy (e.g. prednisone) or other immunosuppressive agents (e.g. methotrexate)
10. Treated autoimmune disorder

Where this trial is running

Markham, Ontario and 4 other locations

• Markham HealthPlex Medical Centre — Markham, Ontario, Canada (Recruiting)
• North York Diagnostic and Cardiac Centre — North York, Ontario, Canada (Not_yet_recruiting)
• Marlee Medical Centre — North York, Ontario, Canada (Recruiting)
• Diagnostic Assessment Centre — Scarborough Village, Ontario, Canada (Not_yet_recruiting)
• Langstaff Medical Centre — Woodbridge, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Cole Dennis, BASc, MSc

Conditions Cardiovascular Diseases Risk; Progenitor Cells; Cardiometabolic Risk; Ethnic Origins