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Trial record 1 of 1 for:    NCT01211028
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Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

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ClinicalTrials.gov Identifier: NCT01211028
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : May 11, 2017
French Blood Establishment
Clinical Research Center, Toulouse
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Cardiovascular Diseases Biological: Expanded autologous ASCs Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
Study Start Date : January 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211028

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University Hospital of Toulouse, Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
French Blood Establishment
Clinical Research Center, Toulouse
Centre National de la Recherche Scientifique, France
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Principal Investigator: Alessandra BURA-RIVIERE, Pr University Hospital of Toulouse, Rangueil
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01211028    
Other Study ID Numbers: 0405402
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Keywords provided by University Hospital, Toulouse:
Critical leg ischemia
Adipose derived Stroma/Stem Cells
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases