Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
ACELLDREAM
Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 11, 2017
May 1, 2017
3.5 years
March 31, 2010
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and Nature of Adverse Events : safety and tolerability
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. \[ Designated as safety issue: Yes \]
15 days, 1, 2, 3, 4,5, 6 months for adverse events record
Study Arms (1)
Autologous ASCs
OTHERExpanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.
Interventions
Drug: Expanded autologous adipose-derived adult stroma/stem cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- French Blood Establishmentcollaborator
- Clinical Research Center, Toulousecollaborator
- Centre National de la Recherche Scientifique, Francecollaborator
Study Sites (1)
University Hospital of Toulouse, Rangueil
Toulouse, 31059, France
Related Publications (1)
Planat-Benard V, Silvestre JS, Cousin B, Andre M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Penicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. doi: 10.1161/01.CIR.0000114522.38265.61. Epub 2004 Jan 20.
PMID: 14734516BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandra BURA-RIVIERE, Pr
University Hospital of Toulouse, Rangueil
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2010
First Posted
September 29, 2010
Study Start
January 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
May 11, 2017
Record last verified: 2017-05