ACELLDream for Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

This study has been completed.
Sponsor:
Collaborators:
Unity Research 5241 UPS/CNRS
French Blood Establishment (Midi-Pyrénées)
Clinical Investigation Centre
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01211028
First received: March 31, 2010
Last updated: June 11, 2014
Last verified: June 2014

March 31, 2010
June 11, 2014
January 2009
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01211028 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
ACELLDream for Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia (ACELLDream for Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine)

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Vascular Diseases
  • Cardiovascular Diseases
Other: Expanded autologous ASCs
Drug: Expanded autologous adipose-derived adult stroma/stem cells
Other Name: Expanded autologous Adipose-derived adult Stroma/Stem cells
Active Comparator: Autologous ASCs
Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.
Intervention: Other: Expanded autologous ASCs
Planat-Benard V, Silvestre JS, Cousin B, André M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Pénicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. Epub 2004 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01211028
0405402
No
University Hospital, Toulouse
University Hospital, Toulouse
  • Unity Research 5241 UPS/CNRS
  • French Blood Establishment (Midi-Pyrénées)
  • Clinical Investigation Centre
Principal Investigator: Alessandra BURA-RIVIERE, Pr University Hospital of Toulouse, Rangueil
University Hospital, Toulouse
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP