Clinical Trials

Phase 3 Clinical Trial of ABCB5+ Stem Cells for RDEB

Date Updated:
EB Type: Recessive Dystrophic Epidermolysis Bullosa 
Name of Company: RHEACELL
Recruitment Status: Active, Not Recruiting

About the Study

RHEACELL is conducting a pivotal placebo-controlled phase III study to investigate the safety and efficacy of ABCB5+ Stem Cells administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB).  

Treatment with ABCB5+ Stem Cells will be given systemically into the bloodstream to target the entire disease spectrum, aiming at improving overall wound burden, reducing disease severity, itching and pain.  

During the trial, 8 infusions of ABCB5+ stem cells or placebo will be administered over 12 months, and enrollees can continue their usual medical care. 

All costs, including travel, lodging, transportation, and food will be covered. 

Trial Entry Criteria

  • Male or female subjects from 6 months of age with a diagnosis of RDEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping; 
  • Subject with a target wound meeting the following criteria: 5-50 cm2, ≥ 21 days and < 9 months, no signs of acute infection 

Visit clinicaltrials.gov for a full list of inclusion and exclusion criteria.

Contacts & Location

If you have any questions or are interested in participating in this clinical trial, please contact:  

Cristina Daniele cristina.daniele@rheacell.com

Locations:

  • Masonic Cancer Center and Medical Center Minneapolis, MN, 55455 
  • Children’s Hospital Colorado, Aurora, CO, 80045 
  • Phoenix Children’s Hospital, Phoenix, AZ, 85016 
  • Stanford Hospital, Redwood City, CA 94305 

Get more information on ClinicalTrials.gov

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