Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
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|ClinicalTrials.gov Identifier: NCT02099500|
Recruitment Status : Withdrawn (no participants enrolled)
First Posted : March 31, 2014
Last Update Posted : July 21, 2017
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for revascularization.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for intramuscular injection into the lower limb.
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Procedure: Liposuction Other: Stem Cell Injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Non-Randomized, Patient Funded, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Via Intramuscular Injections for the Treatment of Critical Limb Ischemia|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: Stem Cell Injection
Liposuction using aspiration syringe and tumescent local anesthesia
Other Name: Adipose-Derived Stem Cells
Other: Stem Cell Injection
Stem cell implantation will be performed using intramuscular injection into the affected ischemic site of interest
- Improvement from baseline in perfusion as measured by ankle-brachial index and collateral artery number [ Time Frame: 6 months ]Contrast Angiography
- Number of adverse events reported [ Time Frame: 6 months ]
- Improvement from baseline in improvement or resolution of ulcer or gangrene [ Time Frame: 3 months, 6 months ]Visual assessment
- Limb Salvage [ Time Frame: 3 months and 6 months ]Assessed with doppler to measure blood flow to the affected area.
- Change from baseline in Quality of Life [ Time Frame: 3 months, 6 months ]King's College Hospital's Vascular Quality of Life Questionnaire
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): NCT02099500
|United States, Florida|
|Miami, Florida, United States, 33180|
|Principal Investigator:||Sharon McQuillan, MD||Ageless Regenerative Institute|