Status:
UNKNOWN
CellMist™ Autologous Cells to Treat Deep Second-Degree Burns
Lead Sponsor:
RenovaCare, Inc
Conditions:
Burns
Burns Second Degree
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The overall purpose of this study is to evaluate the safety of the CellMist™ System in the treatment of deep second degree burns (II°B) in a prospective, multicenter, feasibility pilot study.
Detailed Description
Patients between the ages of 18 and 65 years of age inclusive with a ≤ 30% Total Body Surface Area (TBSA) that requires surgical or enzymatic debridement and split thickness skin grafting (STSG) on an...
Eligibility Criteria
Inclusion
- Is between 18 and 65 years of age inclusive;
- Has at least one discrete deep second degree (II°B) thermal burn injury (≤ 30% Total Body Surface Area (TBSA)) that requires surgical or enzymatic debridement and split thickness skin grafting (STSF) on any body surface excluding the face, joints, perineum and hands;
- Agrees to abstain from any other surgical treatment of the wound(s) for the duration of the study unless determined by the Principal Investigator to be medically necessary;
- Treatment with CellMist™ occurs with 7 days of burn injury;
- Demonstrates (as determined by the Principal Investigator) the ability and willingness to follow the requirements of the protocol;
- Understand the full nature and purpose of the study and provides voluntary written informed consent -
Exclusion
- Is pregnant or does not agree to use acceptable contraception methods for the duration of their participation in the clinical trial (latter applies to women and men of child bearing potential);
- Is breast feeding;
- Has a pre-existing local and/or systemic bacterial infection that requires antibiotic treatment for more than 2 days prior to study treatment;
- Demonstrates an anesthesia risk that (as determined by the Principal Investigator) prohibits treatment
- Body Mass Index (BMI) ≥ 39;
- The burn(s) at the target treatment area(s) results from chemical, electrical or radiation exposure;
- Has full thickness (III°) burns TBSA ≥ 20%
- Has comorbidities and/or medications and/or health status that (as determined by the Principal Investigator) could result in poor cell isolation and/or poor wound healing (e.g., uncontrolled and/or significant diabetes (≥8% HbA1c by medical record), peripheral vascular disease, active malignancy or treatment (other than surgery) of malignancy within the past 3 months, autoimmune disease, renal failure (glomerular filtration rate \<60mL/minute) and/or systemic steroid usage);
- Known hypersensitivities to trypsin, collagenase, or GentLyase (dispase);
- Has a medical condition that would make life expectancy \< 12 months;
- Is currently participating in another prospective investigational clinical trial;
- Does not agree to abstain from enrolling in any other study for the duration of this study;
- Gram staining of SkinGun™ cell suspension output shows excessive microbial bioburden (≥ 200 microbial particles/field)
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04890574
Start Date
May 26 2021
End Date
November 30 2022
Last Update
March 15 2022
Active Locations (1)
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1
Washington MedStar Hospital
Washington D.C., District of Columbia, United States, 20010