Status:
SUSPENDED
Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds
Lead Sponsor:
Cytori Therapeutics
Conditions:
Thermal Burn
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds.
Detailed Description
The RELIEF Trial is a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subj...
Eligibility Criteria
Inclusion
- Males or females age ≥ 18 to ≤ 65
- BMI \> 20 kg/m2
- 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
- Donor site availability for skin graft harvest
- Able to provide written informed consent signed by either the patient or their legally authorized representative
- Women and men of child-bearing potential agreeing to use contraception during the study. Acceptable methods include surgical sterility, IUDs, hormonal contraception or double barrier methods
Exclusion
- Subjects with burns \> 3rd degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
- Subjects with electrical or chemical burns
- Subjects with significant inhalation injuries necessitating intubation and mechanical ventilation or requiring \> 50% FI02 on a continuous basis to maintain oxygenation (02 sat \> 90%)
- In the opinion of treating physician, patient not expected to survive beyond 30 days
- Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids
- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline
- Known history of HIV infection, or active Hepatitis B or active Hepatitis C infection
- Cancer requiring chemotherapy or radiation within previous 6 months or resection within the last 5 years (other than basal cell carcinoma)
- Known chronic renal failure (serum creatinine \> 2 mg/dL) or chronic liver disease
- Pre-existing medical conditions that would interfere with wound healing (i.e.diabetic patients with Hemoglobin A1c test result ≥8%, malignancy, autoimmune disease)
- Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
- Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient compliance with the protocol
- Participation in another clinical trial within 60 days of the screening visit
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03435172
Start Date
April 1 2018
End Date
July 31 2021
Last Update
September 25 2019
Active Locations (5)
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1
Maricopa IHS
Phoenix, Arizona, United States, 85008
2
Univeristy of Southern California
Los Angeles, California, United States, 90033
3
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
4
University of Florida
Gainesville, Florida, United States, 32610