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

Primary Purpose

Epidermolysis Bullosa With Mitten Hands

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Cell transplantation

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa With Mitten Hands focused on measuring Epidermolysis Bullosa mitten hand deformity autologous cultured fibroblast, amniotic membrane

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fibroblast transplant

Arm Description

Transplantation of autologous cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hand deformity

Outcomes

Primary Outcome Measures

Pain

Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.

Infection

Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.

Bleeding

Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.

Healing

Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.

Secondary Outcome Measures

new ulceration

Evaluation the new blister or ulceration during 3 to 6 months after transplantation.

Range of motion

Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.

Full Information

NCT ID

NCT01908088

First Posted

July 23, 2013

Last Updated

July 24, 2013

Sponsor

Royan Institute

Collaborators

Hazrat Fatemeh Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01908088

Brief Title

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

Official Title

Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

Collaborators

Hazrat Fatemeh Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epidermolysis Bullosa With Mitten Hands

Keywords

Epidermolysis Bullosa mitten hand deformity autologous cultured fibroblast, amniotic membrane

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fibroblast transplant

Arm Type

Experimental

Arm Description

Transplantation of autologous cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hand deformity

Intervention Type

Biological

Intervention Name(s)

Cell transplantation

Other Intervention Name(s)

autologous transplantation of cultured fibroblast on amniotic membrane

Intervention Description

autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.

Primary Outcome Measure Information:

Title

Pain

Description

Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.

Time Frame

1month

Title

Infection

Description

Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.

Time Frame

1week

Title

Bleeding

Description

Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.

Time Frame

1week

Title

Healing

Description

Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.

Time Frame

1month

Secondary Outcome Measure Information:

Title

new ulceration

Description

Evaluation the new blister or ulceration during 3 to 6 months after transplantation.

Time Frame

3months

Title

Range of motion

Description

Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.

Time Frame

6months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: