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

University of Minnesota (UMN)

Status: Completed

Conditions: Epidermolysis Bullosa

Treatments: Device: Cellutome Epidermal Harvesting System

Study type: Interventional

Funder types: Other

Identifiers

NCT02670837

2015LS154

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Graft from HCT donor

Experimental group

Description:

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.

Treatment:

Device: Cellutome Epidermal Harvesting System

Self donor from intact skin patch

Experimental group

Description:

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.

Treatment:

Device: Cellutome Epidermal Harvesting System