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Completed

NCT Number: NCT02670837

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

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 non-adherent silicone dressing (Adaptic) to the recipient as a wound dressing.

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Key information

Conditions

Epidermolysis Bullosa Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Masonic Cancer Center and Medical Center

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cellutome Epidermal Harvesting System

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Participants With Lesion Free Skin

    Time frame: 1 year after grafting

    Participants without Squamous cell carcinoma (SCC) at graft site. Wound reassessments will be performed via photographs and follow-up visits.

  2. 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. Wound reassessments will be performed via photographs and follow-up visits.

  3. Percentage Change of a Patient's IScorEB Assessment Score

    Time frame: Baseline and 6 weeks

    Measure percent of changes in quality of life (QOL) through pain, itching, and general QOL IScorEB questionnaire. Scores can range from 16 to 112. The QOLS scores are summed so that a higher score indicates higher quality of life.

  4. Percentage Change of a Patient's IScoreEB Assessment Score

    Time frame: Baseline and 12 weeks

    Measure percent of changes in quality of life (QOL) through pain, itching, and general QOL IScorEB questionnaire. Scores can range from 16 to 112. The QOLS scores are summed so that a higher score indicates higher quality of life.

  5. 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. Wound reassessments will be performed via photographs and follow-up visits.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

Study of Epidermal Grafting Using the CelluTome Epidermal Harvesting System for the Treatment of Individual Lesions in Persons With Epidermolysis Bullosa [MT2015-36]

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Feb 2, 2016
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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