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Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

This study has been completed.
French Blood Establishment (Midi-Pyrénées)
Clinical Research Center, Toulouse
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: March 31, 2010
Last updated: May 10, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Peripheral Vascular Diseases
Cardiovascular Diseases
Biological: Expanded autologous ASCs
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Autologous ASCs
Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.
Biological: Expanded autologous ASCs
Drug: Expanded autologous adipose-derived adult stroma/stem cells
Other Name: Expanded autologous Adipose-derived adult Stroma/Stem cells


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01211028

University Hospital of Toulouse, Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
French Blood Establishment (Midi-Pyrénées)
Clinical Research Center, Toulouse
Centre National de la Recherche Scientifique, France
Principal Investigator: Alessandra BURA-RIVIERE, Pr University Hospital of Toulouse, Rangueil
  More Information

Responsible Party: University Hospital, Toulouse Identifier: NCT01211028     History of Changes
Other Study ID Numbers: 0405402
Study First Received: March 31, 2010
Last Updated: May 10, 2017

Keywords provided by University Hospital, Toulouse:
Critical leg ischemia
Adipose derived Stroma/Stem Cells

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases processed this record on May 25, 2017