1. Home
  2. Approved trials
  3. » فارسی

Efficacy and safety evaluation of extravesicle, derived from Wharton's jelly's mesenchymal cells of the umbilical cord, injection in androgenetic alopecia.

Protocol summary

Study aim
investigating the effect of the extravesicle solution injection on androgenetic alopecia severity based on the Norwood Hamilton scale in men and the Ludwig scale in women 5 months after the start of the therapy. investigating the effect of the extravesicle solution injection on hair density based on the trichoscan images 5 months after the start of the therapy. investigating the effect of the extravesicle solution injection on telogen phase hair count based on the pull test 5 months after the start of the therapy. investigating the side effects of the extravesicle solution injectionin in each treatmen session and 5 months after the start of the therapy.
Design
clinical trial without a control group,phase 1 study on 10 patients
Settings and conduct
10 volunteer patients are selected from dermatology clinic clients at Rasool Hospital according to the inclusion and exclusion criteria. Extravesicle is injected in three treatment sessions at a one month interval.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Ladies and gentlemen with androgenetic alopecia,Age 18 years and above and less than 50 years old,Hamilton score 2 to 5 in men Ludwig score 1 to 3 in women,Complete patient consent to participate in the project Exclusion criteria:Platelet dysfunction,Thrombocytopenia,Anticoagulant drug use,Malignancy,Chemotherapy within 5 years,Sepsis,Smoking,Pregnancy,Ulcer or infection at the site of treatment,Do not receive any topical or systemic medication in the last 3 months,Women with hyperprolactinemia,Women with hormonal dysfunction or polycystic ovarian disease
Intervention groups
A group of 10 people will be treated with extravesicle injection on three treatment sessions. The interval between each treatment session is one month.
Main outcome variables
Change in alopecia severity,telogen phase hair count,hair density,physician assessment,patient assessment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140624018210N13
Registration date: 2022-09-03, 1401/06/12
Registration timing: prospective

Last update: 2022-09-03, 1401/06/12
Update count: 0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety evaluation of extravesicle, derived from Wharton's jelly's mesenchymal cells of the umbilical cord, injection in androgenetic alopecia.
Public title
Efficacy evaluation of extravesicle, derived from Wharton's jelly's mesenchymal cells of the umbilical cord, injection in androgenetic alopecia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ladies and gentlemen with androgenetic alopecia Age 18 years and above and less than 50 years old Hamilton score 2 to 5 in men Ludwig score 1 to 3 in women Complete patient consent to participate in the project
Exclusion criteria:
Platelet dysfunction Thrombocytopenia Anticoagulant drug use Malignancy Chemotherapy within 5 years Sepsis Smoking Pregnancy Ulcer or infection at the site of treatment Do not receive any topical or systemic medication in the last 3 months Women with hyperprolactinemia Women with hormonal dysfunction or polycystic ovarian disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical sciences,Ghods Street,Keshavarz Boulevard,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2021-10-23, 1400/08/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1177

Health conditions studied

1

Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia

Primary outcomes

1

Description
Alopecia severity
Timepoint
Before the start of the trial and two months after the last session
Method of measurement
Rate of change in the clinical severity of alopecia is measured by imaging with visioface. hamilton scale 1 to 6 in men.Ludwig scale 1 to 3 in women

2

Description
The amount of hair in the telogen phase
Timepoint
Before the beginning of the trial and two months after the last session
Method of measurement
The amount of hair in the telogen phase is measured by pull test

3

Description
Hair density
Timepoint
Before the beginning of the trial and two months after the last session
Method of measurement
Hair density is measured by trichoscan

4

Description
Patient satisfaction of treatment
Timepoint
Two months after the last session of treatment
Method of measurement
Patient global assessment score

5

Description
Physician satisfaction of treatment
Timepoint
Two months after the last session of treatment
Method of measurement
Physician global assessment score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: a group of 10 people is treated with extravesicle solution derived from Wharton's jelly's mesenchymal cells of the umbilical cord.The treatment sessions are three sessions with an interval of one month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Tahereh Rahimi
Street address
Rasool Akram Hospital, Niayesh street, Shahara
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6690 9257
Email
mtaherehrahimi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4. Maryam Alley. South Kamranyeh Street, Skin and Stem Cell Research Center
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2221 2537
Email
Afsaneh.najafi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem Cell Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Behrangi
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology Department,Rasool Hospital,Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Behrangi
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology Department,Rasool Hospital,Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Behrangi
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology Department,Rasool Hospital,Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...