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Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435172
Recruitment Status : Suspended (Low enrollment rate, voluntary study suspension of the study)
First Posted : February 15, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Tracking Information
First Submitted Date  ICMJE February 1, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Feasibility of obtain lipo suction with > 100mL adipose tissue, Feasibility if obtain 20 million ADRC [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Percent epithelialization of the graft [ Time Frame: At first dressing change, 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 first dressing change, 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds
Official Title  ICMJE Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF)
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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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 meshed skin graft (STSG) . 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 15 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 STSG are balanced across the treatment groups.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thermal Burn
Intervention  ICMJE Device: Device-ADRCs intravenously infusion
Medical Device: ADRCs Generated by Celution 800 IV Device and then Infused into Peripheral Vein.
Study Arms  ICMJE
  • 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 meshed skin graft (STSG) will be used.
    Intervention: Device: Device-ADRCs intravenously infusion
  • No Intervention: Usual Care
    Standard care of split thickness meshed skin graft (STSG) will be used.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 1, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2018)
30
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 meshed STSG meshed 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.diabetic patients with Hemoglobin A1c test result ≥8%, malignancy, autoimmune disease)
  • Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
  • Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient compliance with the protocol
  • Participation in another clinical trial within 60 days of the screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03435172
Other Study ID Numbers  ICMJE RELIEF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cytori Therapeutics
Study Sponsor  ICMJE Cytori Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc H Hedrick, MD Cytori therapeutics Inc
PRS Account Cytori Therapeutics
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP