Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa

• ClinicalTrials.gov Identifier: NCT01908088
• Recruitment Status: Completed
• First Posted: July 25, 2013
• Last Update Posted: July 25, 2013
• Sponsor: Royan Institute
• Collaborator: Hazrat Fatemeh Hospital
• Information provided by (Responsible Party): Royan Institute

Study Description

Brief Summary:

Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is severe with some morbidity such as mitten hand deformity.

The management of these patients is very difficult because no effective treatment has been known yet.

The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas of hand which is without the skin. In this study the investigators assess the safety of autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for them.

Condition or disease	Intervention/treatment	Phase
Epidermolysis Bullosa With Mitten Hands	Biological: Cell transplantation	Phase 1

Detailed Description:

Epidermolysis Bullosa patients with mitten hand deformity were included. (based on inclusion & exclusion criteria) These patients should be offered for surgery to release the adhesions between fingers and MCP. When the consent form was accepted and the lab test was confirmed, a small skin biopsy was removed from retro auricle and fibroblast cells were separated and cultured. These cells were seeded on AM and the microbial test was done as evidence to prove the safety.

Under general anesthesia, when the hands adhesion was removed, the autologous fibroblast cultured on AM was transplanted to the both hands (specially the area without skin coverage) and the hands were dressed afterward.

The dressing was changed and the wound was checked regularly to detect any complications.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa
• Study Start Date: July 2010
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: fibroblast transplant; Transplantation of autologous cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hand deformity	Biological: Cell transplantation; autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.; Other Name: autologous transplantation of cultured fibroblast on amniotic membrane

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: 1month ]
   Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.
2. Infection [ Time Frame: 1week ]
   Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.
3. Bleeding [ Time Frame: 1week ]
   Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.
4. Healing [ Time Frame: 1month ]
   Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.

Secondary Outcome Measures :

1. new ulceration [ Time Frame: 3months ]
   Evaluation the new blister or ulceration during 3 to 6 months after transplantation.
2. Range of motion [ Time Frame: 6months ]
   Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Both genders Age: 5-25y No history of other systemic disease No history of other cell therapy method No infection in donor or recipient site HCV Ab/HIV Ab/ HBS Ag tests were negative

Exclusion Criteria:

• Age less than 5y or more than 25y. History of other systemic disease History of other cell therapy method Infection in donor or recipient site Positive Lab tests for contagious viral diseases Pregnancy or lactating History of malignancy

Contacts and Locations

Locations

Iran, Islamic Republic of

Royan Institute

Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Royan Institute

Hazrat Fatemeh Hospital

Investigators

• Study Chair: Hamid Gourabi, PhD; Head of Royan Institute
• Study Director: Nasser Aghdami, MD,PhD; Head of Royan Institute Cell Therapy Center
• Study Director: Saeed Shafiyan, MD; Dermatogist,Depatment of Regenerative medicin of Royan Institute
• Principal Investigator: Zahra Orouji, MD; Regenerative Medicine Department of Royan Institute
• Principal Investigator: Kamal Seyed Forootan, MD; Plastic Surgoen, Hazrat Fatemeh Hospital
• Principal Investigator: Seyed Mohammad Javad Fatemi, MD; Plastic Surgoen,Hazrat Fatemeh Hospital

More Information

Additional Information:

Related Info 

• Responsible Party: Royan Institute
• ClinicalTrials.gov Identifier: NCT01908088
• Other Study ID Numbers: Royan-skin-003
• First Posted: July 25, 2013
• Last Update Posted: July 25, 2013
• Last Verified: February 2010

Keywords provided by Royan Institute:

Epidermolysis Bullosa mitten hand deformity autologous cultured fibroblast; amniotic membrane

Additional relevant MeSH terms:

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin Diseases, Vesiculobullous