AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Houssam Farres, M.D.
Study ID
NCT04392206
Phase
PHASE1
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Adipose Derived Mesenchymal Stem Cells — DRUG
    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

Study Details

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.

Key Dates

Start date
May 15, 2020
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adipose Derived Mesenchymal Stem Cells
    Subjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment.

Primary Outcome Measure

Number of participants with treatment-related adverse events [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224
Mauricia Buchanan
[email protected]
904-953-2077

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic in Florida· Jacksonville, FL

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