Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine (ACELLDREAM)

May 10, 2017 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital of Toulouse, Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Autologous ASCs
Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells.
Biological: Expanded autologous ASCs
Drug: Expanded autologous adipose-derived adult stroma/stem cells
Other Names:
  • Expanded autologous Adipose-derived adult Stroma/Stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ]
15 days, 1, 2, 3, 4,5, 6 months for adverse events record

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

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

Investigators

  • Principal Investigator: Alessandra BURA-RIVIERE, Pr, University Hospital of Toulouse, Rangueil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0405402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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