- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01908088
Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa
Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Royan Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fibroblast transplant
Transplantation of autologous cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hand deformity
|
autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 1month
|
Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.
|
1month
|
Infection
Time Frame: 1week
|
Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.
|
1week
|
Bleeding
Time Frame: 1week
|
Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.
|
1week
|
Healing
Time Frame: 1month
|
Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.
|
1month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
new ulceration
Time Frame: 3months
|
Evaluation the new blister or ulceration during 3 to 6 months after transplantation.
|
3months
|
Range of motion
Time Frame: 6months
|
Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.
|
6months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Royan-skin-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epidermolysis Bullosa With Mitten Hands
-
Castle Creek Pharmaceuticals, LLCCompletedDystrophic Epidermolysis Bullosa | Epidermolysis Bullosa Simplex | Junctional Epidermolysis Bullosa | Epidermolysis Bullosa (EB)United States
-
Krystal Biotech, Inc.CompletedDystrophic Epidermolysis Bullosa | Recessive Dystrophic Epidermolysis Bullosa | Dominant Dystrophic Epidermolysis Bullosa | DEB - Dystrophic Epidermolysis BullosaUnited States
-
Krystal Biotech, Inc.CompletedDystrophic Epidermolysis Bullosa | Recessive Dystrophic Epidermolysis Bullosa | Dominant Dystrophic Epidermolysis BullosaUnited States
-
Castle Creek Biosciences, LLC.TerminatedEpidermolysis Bullosa Dystrophica, RecessiveUnited States
-
Instituto de Investigación Hospital Universitario...Instituto de Salud Carlos III; Universidad Carlos III Madrid (TERMeG); St John... and other collaboratorsUnknownEpidermolysis Bullosa Dystrophica, RecessiveSpain
-
Lenus Therapeutics, LLCTerminatedDystrophic Epidermolysis Bullosa | Junctional Epidermolysis BullosaUnited States
-
Holostem Terapie Avanzate s.r.l.IRCCS San Raffaele; University of Modena and Reggio EmiliaRecruitingJunctional Epidermolysis Bullosa Non-Herlitz TypeFrance, Italy
-
Krystal Biotech, Inc.RecruitingDystrophic Epidermolysis Bullosa | Recessive Dystrophic Epidermolysis Bullosa | Dominant Dystrophic Epidermolysis BullosaUnited States
-
Phoenicis TherapeuticsNot yet recruitingDystrophic Epidermolysis BullosaUnited States
-
Thomas Jefferson UniversityOnconova Therapeutics, Inc.RecruitingRecessive Dystrophic Epidermolysis BullosaUnited States
Clinical Trials on Cell transplantation
-
Royan InstituteCompletedVitiligoIran, Islamic Republic of
-
Sidney Kimmel Cancer Center at Thomas Jefferson...WithdrawnAnemia | Thrombocytopenia | Neutropenia | Hematopoietic/Lymphoid Cancer | Lymphopenia
-
Azienda Ospedaliera San Giovanni BattistaUnknownMultiple MyelomaItaly
-
Wake Forest University Health SciencesCompletedLymphoma | Myelodysplastic Syndromes | Leukemia | Chronic Myeloproliferative Disorders | Multiple Myeloma and Plasma Cell NeoplasmUnited States
-
General Hospital of Chinese Armed Police ForcesWithdrawn
-
Roswell Park Cancer InstituteCelgeneWithdrawnRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | IDH2 Gene Mutation | Blasts Under 5 Percent of Peripheral Blood White Cells | Bone Marrow Blasts Decreased by 50 Percent or More Compared to Pretreatment LevelUnited States
-
Royan InstituteCompletedBone CystIran, Islamic Republic of
-
Royan InstituteCompletedNonunion FracturesIran, Islamic Republic of
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedAcute Lymphoblastic Leukemia | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | Myelodysplastic Syndrome | Plasma Cell Myeloma | Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Minimal Residual Disease | Therapy-Related Acute Myeloid Leukemia | Therapy-Related Myelodysplastic... and other conditionsUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityAvailableMalignant Neoplasm | Hematopoietic Cell Transplantation Recipient | Benign Neoplasm | Bone Marrow Transplantation RecipientUnited States