Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

This study has been completed.
Sponsor:
Collaborators:
French Blood Establishment (Midi-Pyrénées)
Clinical Research Center, Toulouse
France: Centre National de la Recherche Scientifique
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01211028
First received: March 31, 2010
Last updated: March 27, 2015
Last verified: March 2015
  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
Other: 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.

Resource links provided by NLM:


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 ]


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
Active Comparator: Autologous ASCs
Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.
Other: 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
France: Centre National de la Recherche Scientifique
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: March 27, 2015
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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 31, 2015