Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
Phase 1
Completed
- Conditions
- Cardiovascular DiseasesPeripheral Vascular Diseases
- Registration Number
- NCT01211028
- Lead Sponsor
- University Hospital, Toulouse
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number and Nature of Adverse Events : safety and tolerability 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 Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which adipose-derived stromal/stem cells promote angiogenesis in critical limb ischemia?
How does autologous adipose-derived cell therapy compare to standard-of-care treatments for peripheral vascular disease in phase 1 trials?
Which biomarkers are associated with successful outcomes in adipose-derived stem cell therapy for ischemic limb conditions?
What are the potential adverse events and safety monitoring strategies for intramuscular ASC administration in cardiovascular disease?
What combination therapies with adipose-derived endothelial cells are being explored for regenerative treatment of peripheral arterial disease?
Trial Locations
- Locations (1)
University Hospital of Toulouse, Rangueil
🇫🇷Toulouse, France
University Hospital of Toulouse, Rangueil🇫🇷Toulouse, France