Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

Toulouse University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Peripheral Vascular Diseases; Cardiovascular Diseases

Treatments: Biological: Expanded autologous ASCs

Study type: Interventional

Funder types: Other

Identifiers

NCT01211028

0405402

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Autologous ASCs

Other group

Description:

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

Treatment:

Biological: Expanded autologous ASCs