Study of Cellutome System for Treatment of Individual Lesions in EB Pts
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/31/2019 |
| Start Date: | August 4, 2016 |
| End Date: | June 2021 |
| Contact: | Kim Nelson, RN |
| Email: | knelso62@fairview.org |
| Phone: | 612-273-2925 |
Study of Epidermal Grafting Using the CelluTome Epidermal Harvesting System for the Treatment of Individual Lesions in Persons With Epidermolysis Bullosa [MT2015-36]
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.
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.
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
We found this trial at
1
site
Minneapolis, Minnesota 55455
Principal Investigator: Christen Ebens, MD, MPH
Phone: 612-273-2925
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