NCT01211028CompletedPhase 1
Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
University Hospital, Toulouse2 sites in 1 country13 target enrollmentStarted: January 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Number and Nature of Adverse Events : safety and tolerability
Study Overview
Brief Summary
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe peripheral vascular disease not amenable to bypass or angioplasty
- •Age >40 years old
- •Normal renal function (creatinine < 1.6)
- •Non pregnant female
- •Lifespan > 6 months
Exclusion Criteria
- •Age <40 years old
- •Refusal to give informed consent and/orCognitively disabled
- •Congestive heart failure or stroke in the last 3 months
- •History of cancer or myeloproliferative disorders
- •Proliferative retinopathy
- •Pregnancy
- •Positive screening test for HIV, Hepatitis B or Hepatitis C
- •Buerger patient
- •Cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue
- •Pregnancy or lactation
- •Having been non controlled severe pathology
Outcomes
Primary Outcomes
Number and Nature of Adverse Events : safety and tolerability
Time Frame: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. \[ Designated as safety issue: Yes \]
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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