NCT02670837

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Epidermolysis Bullosa

Interventions

Type	Name	Description
DEVICE	Cellutome Epidermal Harvesting System

Timeline

• Start date: 2016-08-04
• Primary completion: 2023-03-16
• Completion: 2024-04-03
• First posted: 2016-02-02
• Last updated: 2024-04-09
• Results posted: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study