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Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

T

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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