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CellMist™ Autologous Cells to Treat Deep Second-Degree Burns (CELLMIST1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04890574
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
RenovaCare, Inc

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.

Condition or disease Intervention/treatment Phase
Burns Burns Second Degree Burns Deep Second Degree Device: CellMist™ System Phase 1

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 any body surface excluding the face, joints, perineum and hands will be considered for participation in this study. CellMist™ solution (autologous epidermal and dermal cells) will be administered, via the System Skin Gun™, will be evenly distributed to aid in burn healing. Healing, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning safety of the CellMist™ System will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.

Each subject will participate in up to 9 total visits (screening, treatment and 7 follow-up study visits) over a period of 52 weeks. Up to 14 subjects will be enrolled and treated within this at up to 4 institutions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, single arm, open label non-randomized safety and device feasibility study.
Masking: None (Open Label)
Masking Description: This is a prospective, single arm, open label non-randomized safety and device feasibility study.
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study to Evaluate the CellMist™ System in the Treatment of Deep Second Degree (IIoB) Burn Injuries With Autologous Skin Cells
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : May 26, 2023
Estimated Study Completion Date : August 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns


Intervention Details:
  • Device: CellMist™ System
    Open Label, Safety and Feasibility


Primary Outcome Measures :
  1. All Adverse Events [ Time Frame: We will be evaluating all adverse events reported for the period from enrollment through the final visit which will be 12 months ]
    All Adverse Events will be reported, recorded and analyzed which occur from the time Informed Consent is given through the conclusion of the study. We will be looking at ; Incidence, Severity, Expectedness, Duration, Treatment, and the Relationship to Device for each Adverse Event reported.

  2. Secondary Surgical Interventions [ Time Frame: The evaluation will include all reported secondary surgical interventions for the period from enrollment and up to 12 months ]
    We will be evaluating and analyzing all secondary surgical interventions required to treat the intended target wound. A secondary surgical intervention may include debridement, biopsy, identification of an infectious pathogen, split thickness skin graft, etc...



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is between 18 and 65 years of age inclusive;
  2. 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;
  3. 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;
  4. Treatment with CellMist™ occurs with 7 days of burn injury;
  5. Demonstrates (as determined by the Principal Investigator) the ability and willingness to follow the requirements of the protocol;
  6. Understand the full nature and purpose of the study and provides voluntary written informed consent -

Exclusion Criteria:

  1. 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);
  2. Is breast feeding;
  3. Has a pre-existing local and/or systemic bacterial infection that requires antibiotic treatment for more than 2 days prior to study treatment;
  4. Demonstrates an anesthesia risk that (as determined by the Principal Investigator) prohibits treatment
  5. Body Mass Index (BMI) ≥ 39;
  6. The burn(s) at the target treatment area(s) results from chemical, electrical or radiation exposure;
  7. Has full thickness (III°) burns TBSA ≥ 20%
  8. 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);
  9. Known hypersensitivities to trypsin, collagenase, or GentLyase (dispase);
  10. Has a medical condition that would make life expectancy < 12 months;
  11. Is currently participating in another prospective investigational clinical trial;
  12. Does not agree to abstain from enrolling in any other study for the duration of this study;
  13. Gram staining of SkinGun™ cell suspension output shows excessive microbial bioburden (≥ 200 microbial particles/field)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890574


Contacts
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Contact: Laura Gibson, MPH 919 602 5698 lgibson@renovacareinc.com
Contact: Jo Schweinle, MD 832 776 7662 jschweinle@renovacareinc.com

Locations
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United States, District of Columbia
Washington MedStar Hospital Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey Shupp, MD         
United States, Florida
UF Health Shands Hospital Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Joshua Carson, MD         
United States, Louisiana
University Medical Center New Orleans Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Jeffrey Carter, MD         
Sponsors and Collaborators
RenovaCare, Inc
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Responsible Party: RenovaCare, Inc
ClinicalTrials.gov Identifier: NCT04890574    
Other Study ID Numbers: RC12302017
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by RenovaCare, Inc:
Cell Therapy
Burn Injury
Additional relevant MeSH terms:
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Burns
Wounds and Injuries