Protocol summary

Study aim
evaluation of the safety of intradiscal transplantation of Allogeneic clonal bone marrow derived mesenchymal stromal cells from healthy donor in patients with Discogenic Low Back Pain
Design
patients will enter the study in a regular order. the first patient is monitored for one month and if cell therapy is safe,the second and the third patients will the enter the study and will be monitored. In case of no severe and life-threatening adverse effect the next patients will be included in the study.
Settings and conduct
location: Spine clinic of Yas hospital, operation room of Yas hospital clinical and paraclinical test before injection includes: physical examination , MRI and needed laboratory tests.
Participants/Inclusion and exclusion criteria
patients over 18 years of age with chronic discogenic low back pain whom have not responded to the common conservative management will enter the study willingly following signing the informed consent. Individuals with uncontrolled co-morbidities, any form of spine deformity,coagulopathy, opium and alcohol abuse, pregnancy and breast feeding will be excluded fromthe study.
Intervention groups
injection material: clonal mesenchymal stem cells derived from allogenic bone marrow tissue injection rate: depending on the number of involved levels,intradiscal injection of one to two vials consisting of 9 million bone marrow-derived allogenic mesenchymal cells suspension in 1 ml of normal saline with 1 ml of hyaloronic acid (brand name: Hyalo Brix)
Main outcome variables
no side effects, including short-term and long-term,systrmic or local, and severe or mild,related and unrelated to cell therapy (1 week and 1,3,6 months after the cell transplantation) by reviewing Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080728001031N30
Registration date: 2021-10-21, 1400/07/29
Registration timing: registered_while_recruiting

Last update: 2021-10-21, 1400/07/29
Update count: 0
Registration date
2021-10-21, 1400/07/29
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
Expected recruitment start date
2021-09-23, 1400/07/01
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
Safety evaluation of intra-discal transplantation of allogeneic clonal bone marrow derived mesenchymal stromal cells in patients with low back pain induced by degenerative disc disease: Interventional clinical trial, phase I
Public title
Safety of intra-discal transplantation of allogeneic clonal bone marrow derived mesenchymal stromal cells in patients with low back pain induced by degenerative disc disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years both genders mild to moderate intervertebral disc degeneration in one to three levels Pfirrmann grade 3 to 6 (annulus fibrosus is able to maintain cell transplantation) Modic grade II or less in magnetic resonance imaging (MRI) with or without disc bulging lumbar pain visual analogue scale (VAS) : 3-9 back pain > radiculopathy Oswestry disability index (ODI):30-90 decrease in intervertebral disc height< 30% central disc bulging chronic back pain (atleast for three months in the last six months) which did not respond to symptomatic treatments including physical therapy and medication informed written consent
Exclusion criteria:
body mass index (BMI)>35 kg/m2 Kellgren Knee osteoarthritis grading 3 or more inherited or acquired disease leading to spine deformation,which will impede cell transplantation segmental instability of spine, spine canal stenosis, spondylitis, spondylolisthesis ,other spondyloarthropathies and other diseases that might interfere with the study prior history of disc surgery at the involved or adjacent levels any type of infections or lesions at the site of injection any issue in injection site that may make injection technically impossible prior history of intra-discal injection history of any type of epidural injection in the previous three months any type of neoplasm immuno-compromised or under treatment with immmuno-suppressant agents disrupted hematological or biochemical laboratory results that causes contraindications for the invervention any type of coagulopathy or hemorrhagic diseased or treatment with anticoagulants positive viral tests for HIV, CMV, HCV, HBV, HTLV 1&2 history or clinical diagnosis of severe osteoporosis known uncontrolled co-morbidities eg. diabetes(HbA1C>8%) or organ failure, liver (AST,ALT>100 U/L) kidney (Cr>2) and heart (EF<45%) movement disorders thyroid hormones disruption pregnancy or breast feeding opium or alcohol abuse history or clinical diagnosis of any type of psychosis allergy to substances that exist in culture media eg. gentamycin, bovine or horse serum
Age
From 18 years old
Gender
Both
Phase
1
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
Research Ethics committees of Royan Institute-Academic center for education,culture and research
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
City
tehran
Province
Tehran
Postal code
1951883831
Approval date
2021-07-13, 1400/04/22
Ethics committee reference number
IR.ACECR.ROYAN.REC.1400.040

Health conditions studied

1

Description of health condition studied
chronic discogenic low back pain
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region

Primary outcomes

1

Description
no observed short-term or long term, systemic or local, severe or mild and related or unrelated to cell therapy adverse effects
Timepoint
before intervention, 1 week , 1, 3, 6 months after intervention
Method of measurement
by using CTCAE v5

Secondary outcomes

1

Description
decreased pain after injection
Timepoint
1, 3, 6 months after intervention
Method of measurement
visual analogue scale

2

Description
decrease of patient's disability after injection
Timepoint
1, 3, 6 months after injection
Method of measurement
Oswestry disability index

3

Description
improved quality of life after injection
Timepoint
6 months after injection
Method of measurement
36-item short Form Survey (SF-36)

4

Description
increased disc height after injection
Timepoint
6 months after injection
Method of measurement
MRI

5

Description
increased Apparent diffusion coefficient of intervertebral disc
Timepoint
6 months after injection
Method of measurement
DIFFUSION TENSOR IMAGING in MRI

6

Description
decrease in grading of disc degeneration
Timepoint
6 months after injection
Method of measurement
Scoring Pfirmann using MRI

Intervention groups

1

Description
Intervention group: depending on the number of involved levels,intradiscal injection of one to two vials consisting of 9 million bone marrow-derived allogenic mesenchymal cells suspension in 1 ml of normal saline with 1 ml of hyaloronic acid (brand name: Hyalo Brix)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Masoud Vosough
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
City
tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2251 8388
Email
masvos@yahoo.com

2

Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Ramin Kordi
Street address
District 7, N Villa Rd
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
yashospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ATI tech pharmed
Full name of responsible person
Dr Masoud Vosough
Street address
Golbarg alley. Royan alley. E Hafez St. Bani Hashem St. Soleimani Highway
City
tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 4022 3417
Email
masvos@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ATI tech pharmed
Proportion provided by this source
100
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Mahtab Ahmadi pour
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
City
tehran
Province
Tehran
Postal code
1665664511
Phone
+2122518388
Email
mahtaab.ahmd@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Masoud Vosough
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
City
tehran
Province
Tehran
Postal code
1665664511
Phone
+2122518388
Email
masvos@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
City
tehran
Province
Tehran
Postal code
1665664511
Phone
+21 22518388
Email
hoda62_m@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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