Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Masonic Cancer Center, University of Minnesota
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
