NCT02099500

Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ageless Regenerative Institute · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
PROCEDURE	Liposuction	Liposuction using aspiration syringe and tumescent local anesthesia
OTHER	Stem Cell Injection	Stem cell implantation will be performed using intramuscular injection into the affected ischemic site of interest

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2014-03-31
• Last updated: 2017-07-21

Locations

1 site across 1 country: United States