Trials / Recruiting
RecruitingNCT04392206
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Houssam Farres, M.D. · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adipose Derived Mesenchymal Stem Cells | The dose will be specifically tailored to each subject's vascular anatomy determined by the surgeon through ultrasound measurements. Approximately 3-5 million cells in 5ml Ringer Lactate (RL) Solution |
Timeline
- Start date
- 2020-05-15
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
- First posted
- 2020-05-18
- Last updated
- 2025-08-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04392206. Inclusion in this directory is not an endorsement.