Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.

University Hospital, Toulouse1 site in 1 country13 target enrollmentJanuary 2009

ConditionsPeripheral Vascular Diseases Cardiovascular Diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Peripheral Vascular Diseases
Sponsor: University Hospital, Toulouse
Enrollment: 13
Locations: 1
Primary Endpoint: Number and Nature of Adverse Events : safety and tolerability
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

July 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Toulouse

Responsible Party

Sponsor

Eligibility Criteria

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

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. \[ Designated as safety issue: Yes \]