Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds

NCT03435172 | Suspended DMC FDA Device

• 1 other identifier: RELIEF
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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.

Conditions

Thermal Burn

Keywords

Thermal Burn; Adipose Derived Regenerative Cells; Skin Graft

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Throughout the whole 52 weeks trial evaluation period

Secondary Outcomes (3)

• Percent epithelialization of the graft

  At first dressing change, day 10 and weeks 2, 3 and 4.

• Percent take of the graft

  At first dressing change, day 10 and weeks 2, 3 and 4.

• Percent of wound with complete closure

  At weeks 2, 3, 4, 8 and 12

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Standard care of split thickness meshed skin graft (STSG) will be used.

Interventions

Device-ADRCs intravenously infusion DEVICE

Medical Device: ADRCs Generated by Celution 800 IV Device and then Infused into Peripheral Vein.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytori Therapeutics: lead

Study Sites (5)

Maricopa IHS

Phoenix, Arizona, 85008, United States

Location

Univeristy of Southern California

Los Angeles, California, 90033, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Study Officials

• Marc H Hedrick, MD

  Cytori therapeutics Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 15, 2018
• Study Start: April 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2021
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (5)