Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia (CLI-DI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02234778|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2014
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Device: TGI SVF material via intramuscular injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System™ for Autologous Adipose-Derived Stromal Vascular Fraction Cells to Treat Critical Limb Ischemia|
|Actual Study Start Date :||August 2014|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Study Treatment
Each subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. TGI SVF material injection will be completed within 4 hours of cell separation.
Device: TGI SVF material via intramuscular injection
Each SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period.
- Amputation-Free Survival [ Time Frame: 26 weeks ]To obtain preliminary feasibility evidence of the ability of the Tissue Genesis Inc. (TGI) stromal vascular fraction (SVF) material to result in freedom from major amputation (above the ankle) or death at 26 weeks following treatment. Treatment failure is defined as the composite of major amputation of the treatment limb or all-cause death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234778
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|