Status:
COMPLETED
Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
French Blood Establishment
Clinical Research Center, Toulouse
Conditions:
Peripheral Vascular Diseases
Cardiovascular Diseases
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
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 crit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01211028
Start Date
January 1 2009
End Date
July 1 2012
Last Update
May 11 2017
Active Locations (1)
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1
University Hospital of Toulouse, Rangueil
Toulouse, France, 31059