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Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211028
First Posted: September 29, 2010
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
French Blood Establishment (Midi-Pyrénées)
Clinical Research Center, Toulouse
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
University Hospital, Toulouse
  Purpose
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: None (Open Label)
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

  Eligibility

Information from the National Library of Medicine

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

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
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


Locations
France
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
Investigators
Principal Investigator: Alessandra BURA-RIVIERE, Pr University Hospital of Toulouse, Rangueil
  More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01211028     History of Changes
Other Study ID Numbers: 0405402
First Submitted: March 31, 2010
First Posted: September 29, 2010
Last Update Posted: May 11, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases