Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine

Cardiovascular Diseases Clinical Trial

— ACELLDREAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211028
• Other study ID #: 0405402
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 31, 2010
• Last updated: May 10, 2017
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Toulouse, Rangueil	Toulouse

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre National de la Recherche Scientifique, France, Clinical Research Center, Toulouse, French Blood Establishment (Midi-Pyrénées)

Country where clinical trial is conducted

France, 

References & Publications (1)

Planat-Benard V, Silvestre JS, Cousin B, André M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Pénicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. Epub 2004 Jan 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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