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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
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thermal Burn Device: Device-ADRCs intravenously infusion Not Applicable

Detailed Description:

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
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



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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:

  • Males or females age ≥ 18 to ≤ 65
  • BMI > 20 kg/m2
  • Burn TBSA 20% - 50%
  • At least one deep partial thickness and/or full thickness thermal burn ≥ 250 cm2 on the arms, legs, back, abdomen or chest that is anticipated to be covered with autologous STSG meshed at 2:1 or 3:1 and that has not been treated previously with a biologic dressing such as Alloderm® or Integra®
  • Ability to safely undergo tissue harvest that is anticipated to yield >150mL of adipose tissue at a site that is free from infection
  • Donor site availability for skin graft harvest
  • Able to provide written informed consent signed by either the patient or their legally authorized representative
  • Women and men of child-bearing potential agreeing to use contraception during the study. Acceptable methods include surgical sterility, IUDs, hormonal contraception or double barrier methods

Exclusion Criteria:

  • Subjects with burns > 3rd degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
  • Subjects with electrical or chemical burns
  • Subjects with significant inhalation injuries necessitating intubation and mechanical ventilation or requiring > 50% FI02 on a continuous basis to maintain oxygenation (02 sat > 90%)
  • In the opinion of treating physician, patient not expected to survive beyond 30 days
  • Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids
  • Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline
  • Known history of HIV infection, or active Hepatitis B or active Hepatitis C infection
  • Cancer requiring chemotherapy or radiation within previous 6 months or resection within the last 5 years (other than basal cell carcinoma)
  • Known chronic renal failure (serum creatinine > 2 mg/dL) or chronic liver disease
  • Pre-existing medical conditions that would interfere with wound healing (i.e., diabetes, malignancy, autoimmune disease)
  • Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
  • Chronic illicit drug or alcohol abuse that may interfere with patient compliance with the protocol
  • Participation in another clinical trial within 60 days of the screening visit

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): NCT03435172


Contacts
Contact: John K Fraser, PhD 858-458-0900 ext 5262 jfraser@cytori.com
Contact: Min Zhu, MD 858-458-0900 ext 5247 mzhu@cytori.com

Locations
United States, Arizona
Maricopa IHS Recruiting
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      
Sponsors and Collaborators
Cytori Therapeutics
Investigators
Principal Investigator: Marc H Hedrick, MD Cytori therapeutics Inc
  Study Documents (Full-Text)

Documents provided by Cytori Therapeutics:
Study Protocol  [PDF] November 16, 2017


Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT03435172     History of Changes
Other Study ID Numbers: RELIEF
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 Cytori Therapeutics:
Thermal Burn
Adipose Derived Regenerative Cells
Skin Graft