Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine

University Hospital, Toulouse13 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases

Interventions

Expanded autologous ASCsBIOLOGICAL

Drug: Expanded autologous adipose-derived adult stroma/stem cells

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Toulouse, Rangueil

Toulouse, France

Outcomes

Primary Outcomes

Number and Nature of Adverse Events : safety and tolerability

To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. \[ Designated as safety issue: Yes \]

Time frame: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.