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Study of Cellutome System for Treatment of Individual Lesions in EB Pts

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ClinicalTrials.gov Identifier: NCT02670837
Recruitment Status : Recruiting
First Posted : February 2, 2016
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE August 4, 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Percentage of grafts successfully treated [ Time Frame: 12 weeks after grafting ]
If the body surface area affected by the wound is at least 50% lower at 12 weeks relative to baseline, the graft will be considered successful.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02670837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
  • Safety of grafted skin [ Time Frame: 1 year after grafting ]
    Percentage of patients who have had a 6 week period of lesion free skin by the time they are 1 year post grafting.
  • Longevity of grafted skin [ Time Frame: 1 year after grafting ]
    Percentage of patients who have had a 6 week period of lesion free skin by the time they are 1 year post grafting.
  • Functionality of grafted skin [ Time Frame: 1 year after grafting ]
    Percentage of patients who have had a 6 week period of lesion free skin by the time they are 1 year post grafting.
  • Percentage change of a patient's IScorEB assessment score [ Time Frame: 6 weeks after grafting ]
    Measure changes in quality of life (QOL) through pain, itching, and general QOL IScorEB questionnaire
  • Percentage change of a patient's IScoreEB assessment score [ Time Frame: 12 weeks after grafting ]
    Measure changes in quality of life (QOL) through pain, itching, and general QOL IScorEB questionnaire
  • Seamless, scar-free healing of the body sites of the donor [ Time Frame: 1 year after grafting ]
    Percentage of donors with no evidence of non-healed skin
  • Safety during healing of the body sites of the donor [ Time Frame: 1 year after grafting ]
    Percentage of donors with no evidence of non-healed skin
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Safety of grafted skin [ Time Frame: 1 year after grafting ]
    Percentage of patients with more than 6 weeks of lesion free skin.
  • Percentage change of a patient's IScoreEB [ Time Frame: 6 weeks after grafting ]
  • Percentage change of a patient's IScoreEB [ Time Frame: 12 weeks after grafting ]
  • Safety of the body sites of the donor [ Time Frame: 1 year after grafting ]
    Percentage of donors with no evidence of non-healed skin
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cellutome System for Treatment of Individual Lesions in EB Pts
Official Title  ICMJE Study of Epidermal Grafting Using the CelluTome Epidermal Harvesting System for the Treatment of Individual Lesions in Persons With Epidermolysis Bullosa [MT2015-36]
Brief Summary Few but persistent wounds often remain even after successful hematopoietic cell transplantation for systemic genodermatosis epidermolysis bullosa (EB). The investigators propose local wound therapy using epidermal skin grafting from the same donor that provided the hematopoietic graft, or from the same EB individual with a mosaic (naturally gene corrected) skin. In both cases permissive immune system and skin chimerism is expected to enable long-term epidermal engraftment and wound healing. The investigators will use FDA approved vacuum device (CelluTome®, Regulation number 878.4820) that enables scar-free harvesting of epidermis and its transfer on a square of surgical tape (Tegaderm®) to the recipient as a wound dressing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Epidermolysis Bullosa
Intervention  ICMJE Device: Cellutome Epidermal Harvesting System
Study Arms
  • Experimental: Graft from HCT donor
    Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
    Intervention: Device: Cellutome Epidermal Harvesting System
  • Experimental: Self donor from intact skin patch
    Cells are harvested from the subject using Cellutome, then transferred via Adaptic dressing to that subject's wound with up to 3 harvest sites/treated wound sites on day 0.
    Intervention: Device: Cellutome Epidermal Harvesting System
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
40
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patient (Recipient)

  • Diagnosis of Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB) with at least one wound, visibly free from infection (or previously treated) and meets the eligibility for Arm A or Arm B based on the skin graft source:
  • Cell harvest from previous hematopoietic cell transplantation (HCT) donor (Arm A) - not applicable if Arm B

    • At least 6 months after hematopoietic cell transplantation with donor chimerism

      • Peripheral blood donor chimerism should be measured within 21 days of grafting and be >/= 5% and stable. Stability of chimerism will be determined by the protocol team and based on 3 peripheral blood chimerism values at least 1 month apart.
    • No history of pre-BMT autoimmune cytopenias
    • Off immune suppressive therapy
    • Original transplant donor is available and willing to be the epidermis donor
  • Self-donation (Arm B) - not applicable if Arm A

    • Proven somatic reversion
    • Site for skin grafting free of cellulitis and any other clinically evident abnormalities
    • Meets donor eligibility
  • Insurance pre-authorization for procedure, if applicable
  • Voluntary written consent (patient or parent/guardian for minors with assent) prior to any research related procedures or treatment.

Skin Graft Donor (either hematopoietic cell transplantation donor for the EB patient [Arm A] or EB patient herself/himself [Arm B])

  • Age > 2 years (based on prior safety testing of the device)
  • Healthy on physical examination in the opinion of the evaluating provider
  • Negativity for Hepatitis B and C, HIV, and HTLV1/2 within 30 days of donation
  • Voluntary written consent (donor or parent/guardian for minors with assent) prior to any research related procedures
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts  ICMJE
Contact: Kim Nelson, RN 612-273-2925 knelso62@fairview.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670837
Other Study ID Numbers  ICMJE 2015LS154
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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christen Ebens, MD, MPH Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date January 2019

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