Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds
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|ClinicalTrials.gov Identifier: NCT03435172|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thermal Burn||Device: Device-ADRCs intravenously infusion||Not Applicable|
The RELIEF Trial is a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wounds of > 250 cm2 that is to be autografted with a split thickness skin graft (STSG) meshed at either 2:1 or 3:1. Subjects randomized to ADRCs will undergo small volume fat harvest (100 to 150 mL) performed at initiation of general anesthesia for scheduled burn surgery followed by intravenous delivery of ADRCs within 4 hours following surgery. The lipoaspirate will be processed in the Celution® System to isolate and concentrate ADRCs.
Following informed consent and initial screening assessments, eligible subjects will undergo pre-operative testing. On the procedure day, subjects will be randomized to ADRCs (with usual care) or usual care alone. Low volume lipoharvest will only be performed on subjects randomized to ADRCs in order to obtain 100-150 mL lipoaspirate, which will then be transferred to the Celution® System for processing to isolate and concentrate ADRCs for same-day administration. All treatment will be delivered in a total volume of 10 mL which will be delivered by slow intravenous administration into a peripheral vein.
Following surgery, subjects will be evaluated at day 6 (±1), day 10 (±2) (only if wound dressing change planned) and weeks 2 (±3 days), 3 (±3 days), 4 (±3 days), 8 (±7 days), 12 (±14 days), 26 (±14 days), and 52(±21 days).
The 1st 5 subjects enrolled in active treatment will be observed for adverse events over a 7 day period. If no SAEs occur during that period, for that individual subject, the next subject enrolled in active treatment may be entered with the same 7 day observation period. The safety results of the first 5 subjects will be reviewed by the DMC and their evaluation will be used in conjunction with the clinical data collected to date, and if appropriate, to potentially remove the staggering approach to the study. Enrollment after the first 5 subjects may continue only after the DMC has completed its safety review and recommends continuation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Subjects will have at least one deep partial or full thickness burn wound of ≥ 250 cm2 that is to be autografted with a split thickness skin graft (STSG) meshed at either (2:1 or 3:1). The Subjects will be randomized to treatment or usual care group at 2:1 ratio. Harvested tissue will be processed in the Celution® System to isolate and concentrate ADRCs. Then the subject will be followed by peripheral intravenous delivery of ADRCs within 4 hours of completion of Celution® processing.
Up to 30 subjects will be enrolled. Each subject will contribute up to three qualified wound areas for the analysis. Randomization will be stratified to ensure that the numbers of wounds treated with 2:1 and 3:1 STSG are balanced across the treatment groups.
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF)|
|Estimated Study Start Date :||September 10, 2018|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: Treatment Group
Device-ADRCs intravenously infusion 20 million ADRCs generated by Celution device will be intraveously infused through peripheral vein. Standard care of split thickness skin graft (STSG) meshed at either (2:1 or 3:1) will be used.
Device: Device-ADRCs intravenously infusion
Medical Device: ADRCs Generated by Celution 800 IV Device and then Infused into Peripheral Vein.
No Intervention: Usual Care
Standard care of split thickness skin graft (STSG) meshed at either (2:1 or 3:1) will be used.
- Feasibility [ Time Frame: Procedure day only ]Feasibility will be determined as 1) the ability to obtain > 100 mL adipose tissue during the liposuction surgical procedure (up to one hour for the tissue harvesting procedure), 2) obtain ≥ 20 x 106 ADRCs confirmed by cell counting (up to 4 hours after the liposuction procedure), and 3) deliver the prepared cell dose to the subject within four hours after Celution device completed the process.
- Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: Throughout the whole 52 weeks trial evaluation period ]Safety will be evaluated based on the incidence, type and seriousness of adverse events related to the IV administration of test substance as well as the low volume lipoharvest procedure. Adverse events will be assessed according to the NIH Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for scale grading adverse events.
- Percent epithelialization of the graft [ Time Frame: At day 6, day 10 and weeks 2, 3 and 4. ]Percent epithelialization of the graft post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
- Percent take of the graft [ Time Frame: At day 6, day 10 and weeks 2, 3 and 4. ]Percent take of the graft post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
- Percent of wound with complete closure [ Time Frame: At weeks 2, 3, 4, 8 and 12 ]Percent of wound closure post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
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): NCT03435172
|Contact: John K Fraser, PhD||858-458-0900 ext email@example.com|
|Contact: Min Zhu, MD||858-458-0900 ext firstname.lastname@example.org|
|United States, Arizona|
|Phoenix, Arizona, United States, 85008|
|Contact: Kevin Foster, MD 602-344-5112|
|United States, District of Columbia|
|MedStar Health Research Institute||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Jeffrey Shupp, MD 202-877-7347|
|Principal Investigator:||Marc H Hedrick, MD||Cytori therapeutics Inc|