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.

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital of Toulouse, Rangueil

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expanded autologous ASCs

Biological

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

Other names: Expanded autologous Adipose-derived adult Stroma/Stem cells

Primary outcomes

Number and Nature of Adverse Events : safety and tolerability

Time frame: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record

To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. [ Designated as safety issue: Yes ]

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

Centre National de la Recherche Scientifique, France
Clinical Research Center, Toulouse
French Blood Establishment

Registry information

Official study title

Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.

Acronym: ACELLDREAM

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Sep 29, 2010
Registry last updated: May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed