Protocol summary

Study aim
Evaluation of the safety of allogeneic human Wharton’s jelly-derived mesenchymal stem cell transplantation in patients with lumbar degenerative disc disease: a phase I clinical trial
Design
Phase I clinical trial with one treatment group on 10 patients
Settings and conduct
Stem cell extraction: Knowledge-based production and research company, SinaCell; Stem cell injection: Pourcina Medical and Educational Center, Rasht
Participants/Inclusion and exclusion criteria
10 patients with bulging type of lumbar degenerative disc disease will be included in this study according to the inclusion and exclusion criteria. Written informed consent will be obtained from all the patients. Some inclusion criteria: Male or females between 18 and 60 years of age; Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months; Patients with back pain and radicular pain. Some exclusion criteria: Pregnant or lactating women; Severe coagulation disorders or use of oral anticoagulants; Current or previous history of neoplasm in the last 3 years; Immunosuppressive therapy and corticosteroids.
Intervention groups
Intradiscal injection of a vial containing 10 million allogeneic Wharton’s jelly-derived mesenchymal stem cells in 1 cc of normal saline
Main outcome variables
Safety and tolerability evaluation up to one year; Physical examinations including clinical examination and questionnaires for pain, disability and quality of life, adverse events and paraclinical test results (e.g., CBC count, ESR, CRP, and MRI) at 1, 3, 6 and 12 months.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211021052828N3
Registration date: 2023-09-02, 1402/06/11
Registration timing: prospective

Last update: 2023-09-02, 1402/06/11
Update count: 0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Elham Vojoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 4270
Email address
elhamvojoodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-05, 1402/06/14
Expected recruitment end date
2024-01-04, 1402/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety of allogeneic human Wharton’s jelly-derived mesenchymal stem cell transplantation in patients with lumbar degenerative disc disease: a phase I clinical trial
Public title
Safety and efficacy of umbilical cord Wharton’s jelly-derived mesenchymal stem cell in patients with lumbar degenerative disc disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or females between 18 and 60 years of age Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months Patients with back pain and radicular pain Fibrous ring capable of holding the cell implantation, demonstrated by RMI image (stages 2, 3 and 4 of Adams) Decrease of disc height of more than 20% compared to the adjacent normal disc based on radiographic evaluation Absence of spinal infection Pfirrmann grade III-IV The patient has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol In fertile women with a negative pregnancy test result and acceptance of appropriate methods of contraception Lumbar degenerative disc disease with posterior bulging disc confirmed on MRI Pre-treatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale Pre-treatment baseline Oswestry Disability Index Questionnaire score of at least 30 on the 100-point questionnaire No previous history of spine surgery No history of metabolic, autoimmune (e.g., rheumatoid arthritis) and genetic disease
Exclusion criteria:
Allergy to bovine serum, penicillin or dimethyl sulfoxide (DMSO) Rejection of surgical treatment Congenital or acquired diseases leading to spine deformations that may upset cell application Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study Modic III changes on MRI images Overweight with body mass index (BMI) greater than 35 Pregnant or lactating women, or women planning to become pregnant during the first year (12 months) following cell injection Current or previous history of neoplasm in the last 3 years (excluding basal cell carcinoma) Immunosuppressive therapy and corticosteroids Systemic inflammatory disease (spondylitis, rheumatoid arthritis, etc.) Psychosis and severe personality disorder Potentially active neurological disorder associated with symptoms (e.g., peripheral neuropathy) History or current evidence of alcohol or drug abuse or recreational use of illicit drugs or prescription medications High surgical risk (ASA> IV), or contraindication to anesthesia Previous chemotherapy Uncontrolled hypertension despite receiving optimal medication A patient who has received a lumbar epidural steroid injection within 3 weeks prior to cell injection History of receiving stem/progenitor cell therapy or other biological interventions to repair the target intervertebral disc Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study Severe coagulation disorders or use of oral anticoagulants Contraindications to MRI (history of implantation of cardiovascular and cerebrovascular stents, pacemakers, etc.) Patients who are at risk of surgery in the next 6 months An acute fracture of the spine at the time of enrollment in the study Signs of infection or positive serology for HIV, hepatitis, CMV, or syphilis Recent history of smoking Subjects with severe osteoporosis (with an average T-score of -2.5 or below in the lumbar bone density test) Serious pre-existing medical conditions such as cardiovascular disease, renal disease, liver disease, endocrine disease, cancer, and diabetes mellitus Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >1.5 × upper limit of normal [ULN]), anemia or platelet count of <100 × 109/L
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
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
Research Ethics Committees of Guilan University of Medical sciences
Street address
The old building of the Faculty of Health, in front of 17 Shahrivar Hospital, Namjoo St., Shahid Siadati St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
IR.GUMS.REC.1402.265

Health conditions studied

1

Description of health condition studied
Lumbar degenerative disc disease
ICD-10 code
M51.1+
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy

Primary outcomes

1

Description
Safety and tolerability assessment
Timepoint
Up to 1 year
Method of measurement
Clinical examination, questionnaire, and blood tests

2

Description
Physical examinations, side effects of treatment, and paraclinical test results (such as CBC count, ESR, CRP, and MRI)
Timepoint
Baseline and 1, 3, 6, and 12 months after intervention
Method of measurement
Clinical examination, questionnaires for pain, disability and quality of life, and paraclinical tests

Secondary outcomes

1

Description
Improvement in Visual Analogue Scale (VAS) for pain
Timepoint
Baseline and 1, 3, 6, and 12 months after intervention
Method of measurement
According to the patient's report

2

Description
Improvement in Oswestry Disability Index (ODI)
Timepoint
Baseline and 1, 3, 6, and 12 months after intervention
Method of measurement
Questionnaire

3

Description
Improvement in quality of life
Timepoint
Baseline and 6 and 12 months after intervention
Method of measurement
SF-36 questionnaire

4

Description
Improvement in disc height index (DHI)
Timepoint
Baseline and 6 and 12 months after intervention
Method of measurement
MRI

5

Description
Changes in the signal intensity of the nucleus pulposus (NP) region
Timepoint
Baseline and 6 and 12 months after intervention
Method of measurement
MRI

6

Description
Changes in the Pfirrmann grading
Timepoint
Baseline and 6 and 12 months after intervention
Method of measurement
MRI

7

Description
Assessment of worsening of patients' primary symptoms or performance (will be considered an AE)
Timepoint
Up to 1 year
Method of measurement
Clinical examination, questionnaires for pain, disability and quality of life, and paraclinical tests

Intervention groups

1

Description
Intervention group: Intradiscal injection of Wharton's jelly-derived mesenchymal stem cells to 10 patients with lumbar degenerative disc disease
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Medical and Educational Center, Rasht
Full name of responsible person
Cyrus Emir Alavi
Street address
Poursina Crossroads, Namjoo St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 911 131 7398
Email
Cyrusemiralavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
The old building of the Faculty of Health, in front of 17 Shahrivar Hospital, Namjoo St., Shahid Siadati St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 6394
Fax
+98 13 3333 6395
Email
naghi@gums.ac.ir
Grant name
Rasht University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Elham Vojoudi
Street address
Razi Hospital, Sardare Jangal Blvd.
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Fax
+98 13 3354 2460
Email
elhamvojoodi@yahoo.com
Grant name
Rasht University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
private
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Elham Vojoudi
Position
Assistant Professor, Guilan University of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Razi University Hospital, Sardare Jangal Blvd.
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Fax
+98 13 3376 4257
Email
elhamvojoodi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University Hospital
Full name of responsible person
Elham Vojoudi
Position
Assistant Professor, Guilan University of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Razi University Hospital, Sardare Jangal Blvd.
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Fax
+98 13 3376 4257
Email
elhamvojoodi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University Hospital
Full name of responsible person
Elham Vojoudi
Position
Assistant Professor, Guilan University of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Razi University Hospital, Sardare Jangal Blvd.
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Fax
+98 13 3376 4257
Email
elhamvojoodi@yahoo.com

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
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