Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine

Phase 1

Completed

• Conditions: Cardiovascular Diseases; Peripheral Vascular Diseases
• Interventions: Biological: Expanded autologous ASCs

• 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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

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

Arm && Interventions

Group	Intervention	Description
Autologous ASCs	Expanded autologous ASCs	Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.

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. \[ Designated as safety issue: Yes \]

Trial Locations

Locations (1)

University Hospital of Toulouse, Rangueil; 🇫🇷 Toulouse, France