CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Cellutome Epidermal Harvesting Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02670837
NCT02670837N/ACompleted

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

Masonic Cancer Center, University of Minnesota·interventional·Posted Feb 2, 2016·Updated Apr 9, 2024

In Brief

A clinical study evaluating Cellutome Epidermal Harvesting System for Epidermolysis Bullosa. Completed, enrolled 34 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2, 2016
Enrollment StartAug 4, 2016
Primary CompletionMar 16, 2023
Study CompletionApr 3, 2024
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 10.4 years ago

Interventions

Cellutome Epidermal Harvesting Systemdevice