Evaluating the effectiveness of autologous adipose tissue derived mesenchymal stem cell in repair of torn shoulder rotator cuff tendons (Phase 2 of a Clinical Trial)
Evaluating the effectiveness of adipose-derived stem cell in repair of torn rotator cuff tendons of shoulder
Design
This single blind study is the second phase of a clinical trial. 30 patients will be selected from the clinics of Rasool Hospital and they are divided into two groups of 15 people based on the restricted randomization method.
Settings and conduct
After entering the study, patients will be randomly assigned to one of two intervention and control groups. In the first group (intervention group), the individual's sample is placed in the culture medium, and after performing various laboratory procedures, mesenchymal cells are prepared in the clean room of Motahari Hospital after 2 month and These cells are transferred to the sports medicine department of Rasool Hospital and injected into the torn tendon.second group, which is the control group, does not receive mesenchymal cells.Considering the difference of the intervention implemented in the intervention group with the control group the investigator and the data analyst can be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: More than 30 Years of Age; Shoulder pain; Tendon total tear in shoulder MRI
Exclusion Criteria: Partial tear of tendons; Calcific tendinitis; Shoulder capsulitis
Intervention groups
At first, 20 to 30 cc of fat will be collected by liposuction from the abdomen and the flanks. The fat sample inside a sterile bag containing Dulbecco's Modified Eagle Medium (DMEM) (Sigma) - Aldrich, St. Louis, MO) with penicillin/streptomycin antibiotic, will be transferred to the clean room in the shortest time. After the preparation of mesenchymal stem cell, it would be injected in the torn tendon.
1 cc of sterile water will be injected in the torn tendon in the control group
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100718004409N15
Registration date:2024-05-30, 1403/03/10
Registration timing:prospective
Last update:2024-05-30, 1403/03/10
Update count:0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Parisa Nejati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 0361
Email address
parisanejati@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of autologous adipose tissue derived mesenchymal stem cell in repair of torn shoulder rotator cuff tendons (Phase 2 of a Clinical Trial)
Public title
Adipose tissue derived stem cells in the shoulder rotator cuff tendons tear
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than 30 years of age
Chronic shoulder pain during rest or activity
Positive specific tests of shoulder(Neer, Hawkins, Lift Off, Empty Can, Resisted Rotation, Drop Arm, External Rotation Lag))
Confirmation of total tear of rotator cuff in shoulder MRI
Lack of response to other conservative therapies
Absence of indication for surgery or patient dissatisfaction for Surgery
Exclusion criteria:
Partial tear of tendons
Calcific tendinitis
Shoulder capsulitis
History of malignancy
Contraindication for MRI
Age
From 30 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization method is used for randomization and 30 patients after entering the study will be divided into two intervention and control groups (15 people in each group).The type of treatment according to the number of patients in both groups is written on paper and placed in closed envelopes and poured into a container. A person who is completely unfamiliar with the study process holds the container containing the envelopes in front of the patient and the patient randomly picks up an envelope and after opening the envelope, it is determined which is the patient's group and type of treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering the difference of the intervention implemented in the intervention group with the control group just the investigator and the data analyst can be kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of The Research Vice-Chancellor of Iran University of Medical Sciences
Street address
Vice Chancellor for Research, Second Floor, Medicine Faculty, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-12-05, 1402/09/14
Ethics committee reference number
IR.IUMS.REC.1402.778
Health conditions studied
1
Description of health condition studied
Shoulder Tendons Tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
Pain
Timepoint
Before Intervention and 3, 6 and 12 Months After Intervention
Method of measurement
Visual Analog Scale(VAS)
2
Description
Function of the Shoulder
Timepoint
Before Intervention and 3, 6 and 12 Months After Intervention
Method of measurement
Western Ontario Rotator cuff Index(WORC)Questionnaires and The Disabilities of the Arm, Shoulder, and Hand Outcome Measure (DASH) Questionnaires
Secondary outcomes
1
Description
Shoulder Joint Range of Motion
Timepoint
Befor Injection and 3, 6 and 12 Months After Injection
Method of measurement
Goniometry
2
Description
Rotator cuff Muscles Strength
Timepoint
Befor Injection and 3, 6 and 12 Months After Injection
Method of measurement
Manual strength measurement test
3
Description
The number of times patients need to take Analgesics
Timepoint
Befor Injection and 3, 6 and 12 Months After Injection
Method of measurement
Ask the patient
Intervention groups
1
Description
Intervention group: It Includes 15 Patients and Fat-derived Stem Cell will be Injected into the Shoulder Tendons of All 15 Patients.
Category
Treatment - Other
2
Description
Control group: It includes 15 patients who receive 1 cc sterile water in their shoulder
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Dr. Parisa Nejati
Street address
Department of Sports Medicine, Eighth floor, Building Number 1, Rasool Akram Hospital, Niyayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Email
parisanejati2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Parisa Nejati
Street address
Iran University of Medical Sciences, Hemat Highway Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
parisanejati2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Parisa Nejati
Position
Sports Medicine Specialist, Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Rasoul Akram Hospital, Niayesh Avenue, Satarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
Email
parisanejati2@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Parisa Nejati
Position
Sports Medicine Specialist/ Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Assessment Department, Rasoul Akram Hospital , Niayesh Street , Satarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
Email
parisanejati2@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Parisa Nejati
Position
Spotrs Medicine Specialist, Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Rasoul Akram Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
Email
parisanejati2@gmail.com
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