UnknownPhase 1

CellMist™ Autologous Cells to Treat Deep Second-Degree Burns

United States14 participantsStarted 2021-05-26

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All Adverse Events

Timeframe: We will be evaluating all adverse events reported for the period from enrollment through the final visit which will be 12 months

Secondary Surgical Interventions

Timeframe: The evaluation will include all reported secondary surgical interventions for the period from enrollment and up to 12 months

Trial details

NCT IDNCT04890574

SponsorRenovaCare, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-30

View on ClinicalTrials.gov More Burns trials