What this study is
The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum.
Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.
What's being tested
- Immunoglobulin G
Intervention · BIOLOGICAL
Purified IgG from human serum, delivered via IV
Study details
- Sponsor
- M. Peter Marinkovich
- Conditions
- Epidermolysis Bullosa · Epidermolysis Bullosa Acquisita · Dystrophic Epidermolysis Bullosa · Recessive Dystrophic Epidermolysis Bullosa
- Enrolling
- 8 people
- Starts
- 2025-08-04
- Est. completion
- 2027-03
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
- Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
- Baseline skin blistering greater than 5% total body surface area
- 1 wound at least 20 cm^2 able to be entirely treated with Vyjuvek weekly
- 1 wound at least 20 cm^2 that has never been treated with Vyjuvek
- Ongoing VYJUVEK treatment.
You can't join if
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStanford University
Redwood City, California, United States
- Clinical Research Coordinator · Contact650-723-3439cimino@stanford.edu
- Matt P Marinkovich, MD · Principal investigator
Recruiting
Study team
Sponsor
M. Peter Marinkovich
Study ID 73958
Principal investigator
Matt P Marinkovich, MD
Associate Professor of Dermatology
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.