Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis
Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF)
Doctors at research centers in AZ, CA, DC, FL and OH are recruiting patients with thermal wounds trial a regenerative cell therapy made from the patient’s own adipose(fat tissue)-derived regenerative cells (ADRCs) in the treatment of deep partial and full thickness thermal wounds.
Subjects randomized to ADRCs will undergo small volume fat harvest, at the beginning of scheduled burn surgery for an autografted split thickness meshed skin graft. The lipoaspirate will be processed in the Celution® System to isolate and concentrate ADRCs, followed by intravenous delivery of ADRCs within 4 hours following surgery. Follow up will continue at weeks 2, 3, 4, 8 and 12.
- Be 18 to 65 years of age
- BMI > 20
- Burn TBSA 20% – 50%
- At least one deep partial thickness and/or full thickness thermal burn ≥ 250 cm2 on the arms, legs, back, abdomen or chest that is anticipated to be covered with autologous meshed STSG meshed and that has not been treated previously with a biologic dressing such as Alloderm® or Integra®
- Ability to safely undergo tissue harvest that is anticipated to yield >150mL of adipose tissue at a site that is free from infection
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Lipoaspirate using the Celution System to draw and process the ADRCs will occur at the beginning of a scheduled burn surgery, under general anaesthesia.
- Within 4 hours after burn surgery, the concentrated ADRCs are delivered intravenously.
- Follow up will continue at weeks 2, 3, 4, 8 and 12.
LOCATIONS AND CONTACTS:
Trials will take place at the following locations:
Maricopa IHS in Phoenix, AZ. Map.
Ohio State University in Columbus, OH. Map.
University of Florida in Gainesville, FL. Map.
MedStar Health Research Institute in Washington, DC. Map.
University of Southern California in Los Angeles, CA. Map.
Contact: John K Fraser, PhD | 858-458-0900 ext 5262 | [email protected]
Contact: Min Zhu, MD | 858-458-0900 ext 5247 | [email protected]
Or go online: