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
|Condition or disease||Intervention/treatment||Phase|
|Burns Burns Second Degree Burns Deep Second Degree||Device: CellMist™ System||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|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.|
|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|
- Device: CellMist™ System
Open Label, Safety and Feasibility
- 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.
- 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...
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
|Contact: Laura Gibson, MPH||919 602 firstname.lastname@example.org|
|Contact: Jo Schweinle, MD||832 776 email@example.com|
|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|