Objectives: Evaluation of intra-epidermal injection of autologous epidermal cell suspension effect on repigmentation of patches in vitiligo patients
Design: open-label, non-randomized phase III, single center clinical trial
Parcipitants: Age of at least 12 years old; Stablity of vitiligo at least for one year; Exclusion Criteria: Pregnancy or lactation; active underline disease; Kelloid tendency
Primary Outcome: repigmentation percent
Secondary outcome: Safety of the intervention
Sample size: 300 patients
Intervention: A shaved skin biopsy specimen (one fifth the recipient patch surface area) is taken from the patient`s normally pigmented area on the gluteal region by a hand dermatome, under local anesthesia (lidocaine hydrochloride 20 mg/ml). After dissociating epidermal cells, the Well-dispersed cell suspension is aspirated into 1 ml syringes and injected directly in epidermis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508201031N16
Registration date:2016-05-15, 1395/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-15, 1395/02/26
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology
Expected recruitment start date
2009-01-19, 1387/10/30
Expected recruitment end date
2015-03-18, 1393/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intra-epidermal injection of autologous epidermal cell suspension effect on repigmentation of patches in vitiligo patients
Public title
Vitiligo
Purpose
Treatment
Inclusion/Exclusion 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 and cytotoxic drugs at least for past 6 months
Exclusion Criteria: Pregnancy or lactating; Patients with active disease; Infection at the recipient/donor site; Evidence of köebner in the past; Keloidal tendencies; underline chronic disease
Age
From 12 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
No other feature
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT00631865
Registration date
2008-03-03, 1386/12/13
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Approval date
2007-08-21, 1386/05/30
Ethics committee reference number
86/530/پ
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Percentage of repigmentation
Timepoint
3,6 and 12 months after transplantation
Method of measurement
Physician assessment
Secondary outcomes
1
Description
Safety of the intervention
Timepoint
3,6 and 12 months after transplantation
Method of measurement
Patients history
Intervention groups
1
Description
Intervention: Autologous Transplantation of epidermal cell suspension
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Clinic of Royan Institute
Full name of responsible person
Mahshid Ghasemi
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Hamid Gourabi
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Mahshid Ghasemi
Position
M.D/ Researcher
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
mdmg83@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Nasser Aghdami
Position
M.D,Ph.D
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
nasser.aghdami@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
M.D/ Researcher
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
hoda62_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)