NCT00631865

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 20, 2016

Status Verified

February 1, 2009

Enrollment Period

6 years

First QC Date

March 3, 2008

Last Update Submit

July 18, 2016

Conditions

Vitiligo

Keywords

melanocytes

Outcome Measures

Primary Outcomes (1)

  • percentage of repigmentation

    2 and 4 weeks after transplantation

Secondary Outcomes (1)

  • stability of the achieved repigmentation

    6 months after transplantation

Study Arms (1)

cell transplantation group

EXPERIMENTAL

Epidermal Cell transplantation in patients with vitiligo

Biological: Melanocyte transplantation

Interventions

Melanocyte transplantationBIOLOGICAL

Injection of melanocytes directly in Epidermis

Also known as: cell therapy, cell transplantation
cell transplantation group

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant patients
  • Patients with active disease
  • Infection at the recipient site
  • Evidence of köebner in the past
  • Keloidal tendencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Tehran Province, 1665659911, Iran

Location

Related Publications (1)

  • Khodadadi L, Shafieyan S, Sotoudeh M, Dizaj AV, Shahverdi A, Aghdami N, Baharvand H. Intraepidermal injection of dissociated epidermal cell suspension improves vitiligo. Arch Dermatol Res. 2010 Oct;302(8):593-9. doi: 10.1007/s00403-010-1034-7. Epub 2010 Apr 4.

    PMID: 20364383DERIVED

Related Links

MeSH Terms

Conditions

Vitiligo

Interventions

Cell- and Tissue-Based TherapyCell Transplantation

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hossein Baharvand, PhD

    Head of Royan stem cell department

    PRINCIPAL INVESTIGATOR

  • Saeeid Shafieian, MD

    Firoozgar Hospital

    PRINCIPAL INVESTIGATOR

  • Nasser Aghdami, MD., PhD

    Head of Royan transplantation Lab

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2008

First Posted

March 10, 2008

Study Start

February 1, 2009

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

July 20, 2016

Record last verified: 2009-02

Locations

IR(1)