Back to resultsAdipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)
Primary Purpose
Peripheral Vascular Diseases, Cardiovascular Diseases
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Expanded autologous ASCs
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring Critical leg ischemia, Adipose derived Stroma/Stem Cells, Autologous, Angiogenesis
Eligibility 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
Sites / Locations
- University Hospital of Toulouse, Rangueil
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Autologous ASCs
Arm Description
Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.
Outcomes
Primary Outcome Measures
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 ]
Secondary Outcome Measures
Full Information
NCT ID
NCT01211028
First Posted
March 31, 2010
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
Collaborators
French Blood Establishment, Clinical Research Center, Toulouse, Centre National de la Recherche Scientifique, France
1. Study Identification
Unique Protocol Identification Number
NCT01211028
Brief Title
Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
Acronym
ACELLDREAM
Official Title
Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
French Blood Establishment, Clinical Research Center, Toulouse, Centre National de la Recherche Scientifique, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases, Cardiovascular Diseases
Keywords
Critical leg ischemia, Adipose derived Stroma/Stem Cells, Autologous, Angiogenesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous ASCs
Arm Type
Other
Arm Description
Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.
Intervention Type
Biological
Intervention Name(s)
Expanded autologous ASCs
Other Intervention Name(s)
Expanded autologous Adipose-derived adult Stroma/Stem cells
Intervention Description
Drug: Expanded autologous adipose-derived adult stroma/stem cells
Primary Outcome Measure Information:
Title
Number and Nature of Adverse Events : safety and tolerability
Description
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. [ Designated as safety issue: Yes ]
Time Frame
15 days, 1, 2, 3, 4,5, 6 months for adverse events record
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra BURA-RIVIERE, Pr
Organizational Affiliation
University Hospital of Toulouse, Rangueil
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse, Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
14734516
Citation
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.
Results Reference
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Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
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