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ACELLDream for Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (A CELL DREAM)

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Toulouse
Sponsor:
Collaborators:
UMR 5241 UPS/CNRS
French Blood Establishment (Midi-Pyrénées)
Center for Clinical Investigations - Biotherapy - Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01211028
First received: March 31, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  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 intramusculary in patients with critical leg ischemia.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia (ACELLDream for Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. [ Designated as safety issue: Yes ]


Estimated Enrollment: 15
Study Start Date: January 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous ASCs
Autologous ASCs: Experimental Intramuscular dose of 100 million expanded cells.
 Other: Drug: Expanded autologous ASCs
Drug: Expanded autologous adipose-derived adult stroma/stem cells
Other Name: Expanded autologous adipose-derived adult stroma/stem cells

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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 femelle
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211028

Contacts
Contact: Alessandra BURA-RIVIERE, Pr 5 61 32 30 31 ext +33 bura-riviere.a@chu-toulouse.fr

Locations
France
University Hospital of Toulouse, Rangueil Recruiting
Toulouse, France, 31059
Contact: Alessandra BURA-RIVIERE, Pr     5 61 32 30 31 ext +33     bura-riviere.a@chu-toulouse.fr    
Contact: Louis CASTEILLA, Pr     5 62 17 08 91 ext +33        
Principal Investigator: Alessandra BURA-RIVIERE, Pr            
Sponsors and Collaborators
University Hospital, Toulouse
UMR 5241 UPS/CNRS
French Blood Establishment (Midi-Pyrénées)
Center for Clinical Investigations - Biotherapy - Toulouse
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
Study First Received: March 31, 2010
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 23, 2013