Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds (NCT03435172) | Clinical Trial Compass
SuspendedNot Applicable
Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds
Stopped: Low enrollment rate, voluntary study suspension of the study
United States15 participantsStarted 2018-04-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 pr…
What they're measuring
1
Feasibility of obtain lipo suction with > 100mL adipose tissue, Feasibility if obtain 20 million ADRC
Timeframe: Procedure day only
2
Incidence of Treatment-Emergent Adverse Events [Safety]
Timeframe: Throughout the whole 52 weeks trial evaluation period