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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01908088 |
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Date of registration:
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23/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa
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Scientific title:
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Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01908088 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Kamal Seyed Forootan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Plastic Surgoen, Hazrat Fatemeh Hospital |
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Name:
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Saeed Shafiyan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dermatogist,Depatment of Regenerative medicin of Royan Institute |
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Name:
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Nasser Aghdami, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Royan Institute Cell Therapy Center |
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Name:
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Zahra Orouji, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Regenerative Medicine Department of Royan Institute |
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Name:
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Hamid Gourabi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Royan Institute |
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Name:
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Seyed Mohammad Javad Fatemi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Plastic Surgoen,Hazrat Fatemeh Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
5 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epidermolysis Bullosa With Mitten Hands
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Intervention(s)
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Biological: Cell transplantation
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Primary Outcome(s)
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Pain
[Time Frame: 1month]
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Healing
[Time Frame: 1month]
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Bleeding
[Time Frame: 1week]
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Infection
[Time Frame: 1week]
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Secondary Outcome(s)
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new ulceration
[Time Frame: 3months]
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Range of motion
[Time Frame: 6months]
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Secondary ID(s)
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Royan-skin-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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