Cardiovascular Diseases, Peripheral Vascular Diseases
Conditions
Keywords
Critical leg ischemia, Adipose derived Stroma/Stem Cells, Autologous, Angiogenesis
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.
Interventions
BIOLOGICALExpanded autologous ASCs
Drug: Expanded autologous adipose-derived adult stroma/stem cells
Sponsors
French Blood Establishment
Clinical Research Center, Toulouse
Centre National de la Recherche Scientifique, France
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. \[ Designated as safety issue: Yes \] |
Countries
France
Outcome results
None listed