Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine

NCT ID: NCT01211028

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Vascular Diseases Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous ASCs

Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.

Group Type OTHER

Expanded autologous ASCs

Intervention Type BIOLOGICAL

Drug: Expanded autologous adipose-derived adult stroma/stem cells

Interventions

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Expanded autologous ASCs

Drug: Expanded autologous adipose-derived adult stroma/stem cells

Intervention Type BIOLOGICAL

Other Intervention Names

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Expanded autologous Adipose-derived adult Stroma/Stem cells

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Blood Establishment

OTHER

Sponsor Role collaborator

Clinical Research Center, Toulouse

OTHER

Sponsor Role collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandra BURA-RIVIERE, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse, Rangueil

Locations

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University Hospital of Toulouse, Rangueil

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 14734516 (View on PubMed)

Other Identifiers

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0405402

Identifier Type: -

Identifier Source: org_study_id

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