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

This study has been completed.
Sponsor:
Collaborator:
Hazrat Fatemeh Hospital
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01908088
First received: July 23, 2013
Last updated: July 24, 2013
Last verified: February 2010
  Purpose

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 Intervention Phase
Epidermolysis Bullosa With Mitten Hands
Biological: Cell transplantation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Pain [ Time Frame: 1month ] [ Designated as safety issue: Yes ]
    Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.

  • Infection [ Time Frame: 1week ] [ Designated as safety issue: Yes ]
    Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.

  • Bleeding [ Time Frame: 1week ] [ Designated as safety issue: Yes ]
    Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.

  • Healing [ Time Frame: 1month ] [ Designated as safety issue: Yes ]
    Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.


Secondary Outcome Measures:
  • new ulceration [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
    Evaluation the new blister or ulceration during 3 to 6 months after transplantation.

  • Range of motion [ Time Frame: 6months ] [ Designated as safety issue: Yes ]
    Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.


Enrollment: 6
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 25 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908088

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:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01908088     History of Changes
Other Study ID Numbers: Royan-skin-003
Study First Received: July 23, 2013
Last Updated: July 24, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Epidermolysis Bullosa mitten hand deformity autologous cultured fibroblast
amniotic membrane

Additional relevant MeSH terms:
Epidermolysis Bullosa
Hand Deformities
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 15, 2014