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Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT00631865
First received: March 3, 2008
Last updated: June 13, 2011
Last verified: February 2009
  Purpose

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.


Condition Intervention Phase
Vitiligo
Biological: Melanocyte transplantation
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • percentage of repigmentation [ Time Frame: 2 and 4 weeks after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • stability of the achieved repigmentation [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cell transplantation group
Epidermal Cell transplantation in patients with vitiligo
Biological: Melanocyte transplantation
Injection of melanocytes directly in Epidermis
Other Names:
  • cell therapy
  • cell transplantation

Detailed Description:

Vitiligo is a pigmentation disorder in which white patches of skin appear on different parts of the body. Histologically it is characterized by absence of melanocytes along the epidermal basal layer.

Using cell suspension with non-cultured melanocytes which injected into blister of depigmented lesion, a success rate of 85% was reported for repigmentation. However there are some limitations in this technique: the induction of blister is limited to several sites of the body, hypo-pigmentation around the recipient area due to cryodamage of peripheral melanocytes and leakage of suspension out of the blister. To reduce these problems, in this study we will inject melanocytes directly to epidermis.

A shaved biopsy specimen (about 1 cm2) is taken from the patient`s normally pigmented area under local anesthesia (lidocaine hydrochloride 20 mg/ml). The specimens are incubated in 0.25% trypsin solution for 15 minutes at 37°C 0.02% EDTA solution for 10 minutes. Then epidermal sheets are gently manipulated with forceps to dissociate the epidermal cells and to yield a cell suspension, followed by treatment with 0.5% trypsin/versene solution at 37C for 3-5 minutes. Well-dispersed cell suspension is aspirated into 1 ml syringes and injected directly in epidermis.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 12 years
  • Stable form of vitiligo (no increase in the size of the lesion for at least one year)
  • No use of immunosuppressive & cytotoxic drugs at least for past 6 months

Exclusion Criteria:

  • Pregnant patients
  • Patients with active disease
  • Infection at the recipient site
  • Evidence of köebner in the past
  • Keloidal tendencies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631865

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 1665659911
Sponsors and Collaborators
Royan Institute
Investigators
Principal Investigator: Hossein Baharvand, PhD Head of Royan stem cell department
Principal Investigator: Saeeid Shafieian, MD Firoozgar Hospital
Study Director: Nasser Aghdami, MD., PhD Head of Royan transplantation Lab
  More Information

Additional Information:
No publications provided by Royan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hamid Gourabi, Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT00631865     History of Changes
Other Study ID Numbers: Royan-skin-001
Study First Received: March 3, 2008
Last Updated: June 13, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Royan Institute:
melanocytes

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014