An interventional study of Device-ADRCs intravenously infusion in Thermal Burn, sponsored by Cytori Therapeutics. Suspended at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Cytori Therapeutics · Not applicable, Interventional, and Treatment
The primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds.
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 meshed skin graft (STSG). 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 first dressing change, 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.
Exclusion Criteria:
Device-ADRCs intravenously infusion 20 million ADRCs generated by Celution device will be intraveously infused through peripheral vein. Standard care of split thickness meshed skin graft (STSG) will be used.
Device: Device-ADRCs intravenously infusion
Standard care of split thickness meshed skin graft (STSG) will be used.
Medical Device: ADRCs Generated by Celution 800 IV Device and then Infused into Peripheral Vein.
Feasibility of obtain lipo suction with > 100mL adipose tissue, Feasibility if obtain 20 million ADRC
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.
Time frame: Procedure day only
Incidence of Treatment-Emergent Adverse Events [Safety]
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.
Time frame: Throughout the whole 52 weeks trial evaluation period
Percent epithelialization of the graft
Percent epithelialization of the graft post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
Time frame: At first dressing change, day 10 and weeks 2, 3 and 4.
Percent take of the graft
Percent take of the graft post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
Time frame: At first dressing change, day 10 and weeks 2, 3 and 4.
Percent of wound with complete closure
Percent of wound closure post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
Time frame: At weeks 2, 3, 4, 8 and 12
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Cytori Therapeutics