Safety and Preliminary Efficacy Study of Engineered Epidermal Autograft in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036109

Enrollment

Unknown

Registered

2020-08-21

Start date

2020-09-01

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Interventions

1:Epidermal Autograft

Eligibility

Sex/Gender

All

Age

14 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) Clinical diagnosis of RDEB, biallelic recessive COL7A1 mutations (compound heterozygous or homozygous) inherited from biological parents confirmed by genetic testing; 2) Detectable deficiency of COL7A1 expression; 3) Age 14-40, adults preferred; 4) Both sexes/genders; 5) Able to undergo anesthesia necessary for transplantation surgery; 6) Subjects understand and sign informed consent (for subjects under 18 years old, signed ICF also required for their legal guardians).

Exclusion criteria

Exclusion criteria: 1) Apparent evidence of malnutrition (e.g. BMI<18kg/m2) as determined by investigators; 2) Presence of pemphigus or pemphigoid antibodies or COL7A1 autoantibody; 3) History of allogeneic skin transplantation or treatment by recombinant COL7A1 proteins; 4) History of confirmed or suspected squamous skin carcinoma on planned transplantation area; 5) Women in pregnancy or breast-feeding; 6) Subjects that cannot comply with contraceptive measures during the study period; 7) Addiction to drugs or alcohol; 8) Allergy to gentamicin; 9) Participation in other clinical trials in the last 30 days; 10) Subjects with plans to undergo major surgery or other complex therapies; 11) Presence of other severe genetic or non-genetic diseases expected to compromise the safety of the study or complicate the interpretation of study results, including but not limited to: active severe infection, poorly controlled acute/chronic cardiac or pulmonary disease, abnormal liver or renal function, diabetes, autoimmune diseases, malignant tumors. 12) Other Clinically significant medical conditions as determined by investigators.

Design outcomes

Primary

Measure	Time frame
Adverse events from first transplantation to 12 months after the last transplantation;	—

Secondary

Measure	Time frame
Graft integration rates;Healing of subject wounds;Expression of COL7A1;Formation of anchoring fibrils;	—

Countries

China

Contacts

Public ContactYong Yang

Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

yyang@pumcderm.cams.cn+86 17888103998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026