Clinical Trials – US

Clinical Trials – US

Studies on the safety and efficacy of SVF in animal studies and recent clinical trials (IDE pilot studies) provide insight and knowledge into a growing body of research for various acute and chronic medical conditions.

CAUTION: Investigational device. Limited by law in the United States to investigational use.

Evaluation of the Tissue Genesis® Icellator Cell Isolation SystemTM to Treat Critical Limb Ischemia

Status: Active, not recruiting
Conditions: Critical Limb Ischemia

Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction

Status: Not yet recruiting
Conditions: Erectile Dysfunction

Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device

Status: Completed
Conditions: Facial Injuries, Tissue Injury

AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized

Status: Active, not recruiting
Conditions: Wounded Warrior, Limb Shortening, Amputation

Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction

Status: Active, not recruiting
Conditions: Erectile Dysfunction

Stromal Vascular Fraction for Treatment of Xerostomia

Status: Withdrawn
Conditions: Xerostomia Due to Radiotherapy (Disorder)

Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

Status: Not yet recruiting
Conditions: Rotator Cuff Tear, Muscle Atrophy, Tendon Tear

Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft

Status: Active, not recruiting
Conditions: Lower Limb Ischemia

Applications – OUS

Applications OUS

The Icellator® has already been approved for commercial use in Korea as a Class III medical device by the Korean FDA (KMFDS) and has been used in more than 1,200 commercial applications. The Bahamas have also given regulatory approval for Tissue Genesis’s patented, clinical grade cell therapy processing solutions, including the Icellator®2.

Asia

Japan Japan: In clinical use.
South Korea South Korea: In clinical and commercial use.

North America & the Caribbean

USA: Approved for Investigational Use under IDEs for various indications.
Bahamas: In clinical and commercial use.