Study the effect of intravenous injection of dental pulp mesenchymal stem cells in treatment of patients with Limb-Girdle Muscular Dystrophy (LGMD)- A Phase 1 & 2 Clinical Trial
Determining the effect of intravenous injection of dental pulp mesenchymal stem cells in the treatment of patients with Limb-Girdle Muscular Dystrophy (LGMD) - Phase 1 and 2 clinical trial
Design
Clinical trial without control group, community based, not blinded, Non-randomised controlled study
Settings and conduct
This study is being conducted in the field of muscular dystrophy at the Comprehensive Stem Cell Center of Kerman University of Medical Sciences and Shafa Hospital of Kerman. After the patient is selected by the physician and the mesenchymal stem cells from the pulp of the primary tooth are prepared, these cells are injected intramuscularly at a rate of 40 million per kilogram of body weight, and the results before and after the injection are compared.
Participants/Inclusion and exclusion criteria
A- Inclusion criteria:
-Age between 18 and 95 years
- Patients confirmed to have Limb-Girdle muscular dystrophy by definitive laboratory methods
- Exclusion criteria
- Patients undergoing other clinical trials.
Intervention groups
Intervention group: In the intervention group, after selecting patients, stem cell samples will be injected intramuscularly at a rate of 40 million per kilogram of body weight. The patients' results will be reviewed 14 and 28 days after the injection, and the results before and after the injection will be compared.
Main outcome variables
Examination of clinical symptoms and electromyography of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140911019125N13
Registration date:2025-03-10, 1403/12/20
Registration timing:prospective
Last update:2025-03-10, 1403/12/20
Update count:0
Registration date
2025-03-10, 1403/12/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2027-04-21, 1406/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of intravenous injection of dental pulp mesenchymal stem cells in treatment of patients with Limb-Girdle Muscular Dystrophy (LGMD)- A Phase 1 & 2 Clinical Trial
Public title
Investigating the effect of mesenchymal stem cells in patients with muscular dystrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 95 years
Patients confirmed to have Limb-Girdle Muscular Dystrophy by definitive laboratory methods
Exclusion criteria:
Patients undergoing other clinical trials.
Age
From 18 years old to 95 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
5
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 Kerman University Of Medical Science
Street address
Haft Bagh Blvd, Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.KMU.REC.1400.345
Health conditions studied
1
Description of health condition studied
Treatment of patients with muscular dystrophy
ICD-10 code
M63.8
ICD-10 code description
Disorders of muscle in diseases classified elsewhere
Primary outcomes
1
Description
clinical symptoms
Timepoint
14 and 28 days after mesenchymal stem cell injection
Method of measurement
Questionnaire and clinical examination
2
Description
Electromyography
Timepoint
14 and 28 days after mesenchymal stem cell injection
Method of measurement
Check with the device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after selecting patients, stem cell samples will be injected intramuscularly at a rate of 40 million per kilogram of body weight. The patients' results will be reviewed 14 and 28 days after the injection, and the results before and after the injection will be compared.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital, KermanHabibenejad Biglari
Full name of responsible person
Habibe nejad Biglari
Street address
Shafa Medical Training Center, Kowsar Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
habibe.biglari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Sharifi
Street address
kerman university of medical science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3226 3855
Email
hsharifi@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
kerman university of medical science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Kerman University Of Medical Science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Kerman University Of Medical Science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
The data will be available for people working in academic institutions and clinicians.
Under which criteria data/document could be used
Applicants are only allowed to use received data in clinical and they are not allowed to published them.
From where data/document is obtainable
1- Phone: 034-31325374 2- e-mail: afarsinejad@kmu.ac.ir 3- Fax: 034-31325375 4- address: Haft bagh Blvd, Kerman university of medical science Dr. Alireza Farsinejad
What processes are involved for a request to access data/document
Applicant can receive information after contact and send e-mail up to 10 days.