Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Alfred Lane, Stanford University
ClinicalTrials.gov Identifier:
NCT01454687
First received: October 13, 2011
Last updated: April 10, 2014
Last verified: April 2014

October 13, 2011
April 10, 2014
October 2011
April 2014   (final data collection date for primary outcome measure)
  • Expression of the correct protein at the basement membrane zone [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Engraftment and healing of wounds with genetically revertant keratinocytes [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01454687 on ClinicalTrials.gov Archive Site
  • Engraftment and healing of wounds with genetically revertant keratinocytes [ Time Frame: Week 8-12 ] [ Designated as safety issue: No ]
  • Engraftment and healing of wounds with genetically revertant keratinocytes [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
  • Expression of correct protein at the basement membrane zone [ Time Frame: Week 8-12 ] [ Designated as safety issue: No ]
  • Expression of the correct protein at the basement membrane zone [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
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Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes
Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes

The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases associated with skin weakness, blisters, and chronic wounds. "Revertant mosaicism" means that there are two genetically different populations of cells due to spontaneous mutations. Some EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism. In the revertant areas, the proteins function normally, like non-EB skin. In this study, we plan to culture cells from the revertant areas and graft them on to the wounded areas.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epidermolysis Bullosa
Procedure: Grafting of Autologous Cultured Revertant Keratinocytes
Grafting of two to four epidermal sheets 40cm2 - 50cm2 onto wounded areas
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of EB (simplex, junctional or dystrophic)
  • Areas of revertant skin that has been confirmed by biopsy
  • 18 years or older subject willing and able to give consent
  • Confirmation of EB diagnosis by immunofluorescence (IF), electron microscopy (EM), and genetic testing confirming mutation
  • At least 100 to 200 cm2 of open erosions on the trunk and/or extremities suitable for skin grafting
  • Able to undergo adequate anesthesia to allow grafting procedures to take place

Exclusion Criteria:

  • Medical instability limiting ability to travel to Stanford University Medical Center
  • The presence of medical illness expected to complicate participation and/or compromise the safety of this technique
  • Active infection with HIV, hepatitis B, or hepatitis C
  • Active infection in the area that will undergo grafting
  • Evidence of a systemic infection
  • Current evidence or a history of skin cancer in the area that will undergo grafting
  • Active drug or alcohol addiction
  • Hypersensitivity to vancomycin or amikacin
  • Receipt of chemical or biological study product for the specific treatment ofEB in the past six months
  • Positive pregnancy test or breast-feeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01454687
IRB # 22005
No
Alfred Lane, Stanford University
Stanford University
Not Provided
Principal Investigator: Alfred Lane, MD Stanford University
Stanford University
April 2014

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