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.
- 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.
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
