The effect of intra-discal implantation of autologous adipose-derived mesenchymal stem cells in patients with chronic discogenic low back pain
Design
Clinical trial without control group, 10 patients sample size, Trial phase 2-3
Settings and conduct
Tertiary regional and teaching hospital. Participants including major eligibility criteria, among the patients who were candidates for intra-discal implantation of autologous adipose-derived mesenchymal stem cells referred to the Akhtar Hospital in 2019, 10 were selected by Sequential method. Intra-discal implantation of mesenchymal stem cells is done under fluoroscopic guidance at the pathology level. Main outcome measures (variables): Pain Level; Disability.
Participants/Inclusion and exclusion criteria
Aged 18 years and older; Chronic discogeneic symptoms; Lack of response to traditional therapies; Pain based on VAS more than 4; Disability more than 30%
Intervention groups
Intervention group: Intra-discal implantation of autologous adipose-derived mesenchymal stem cells in the target area.
Main outcome variables
Pain Level; Disability.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131124015515N4
Registration date:2019-01-10, 1397/10/20
Registration timing:prospective
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Masoud Hashemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
dr.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intra-discal implantation of autologous adipose-derived mesenchymal stem cells in patients with chronic discogenic low back pain
Public title
Effect of Injection of Fat Stem Cells in Treatment of Lumbar Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years; Signs of chronic discogenic pain for at least three months; Severity of pain based on VAS from 4 to above; Disability level of more than 30%; Failed to respond to traditional therapies; Local anesthetic infiltration in the facet joint / medial branches; Intervertebral disk degeneration with mean grade; Symptoms diagnostic disk with discography confirmation; Signed written informed consent to participate in the study
Exclusion criteria:
History of lumbosacral surgery; Severe disc herniation; Spinal stenosis requiring surgery; Modic type III; Evidence of spinal anesthesia in MRI; Collapse of the disc space of over 50%; Uncontrolled blood pressure despite receiving appropriate treatment; Uncontrolled diabetes despite treatment Suitable; Other serious symptomatic diseases (cancers, autoimmune disease, blood disease, kidney, liver); Pregnancy; Lactation
Age
From 18 years old
Gender
Both
Phase
2-3
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
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Street address
Tabnak St.,Tehran, Tehran, Iran, Islamic Republic Of
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-12-08, 1397/09/17
Ethics committee reference number
IR.SBMU.REC.1397.045
Health conditions studied
1
Description of health condition studied
Chronic discogenic low back pain
ICD-10 code
M51.36
ICD-10 code description
Other intervertebral disc degeneration, lumbar region
Primary outcomes
1
Description
Pain Level
Timepoint
Before treatment, 1, 3, 6, 9 and 12 months after treatment
Before treatment, 1, 3, 6, 9 and 12 months after treatment
Method of measurement
Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intra-discal implantation of autologous adipose-derived mesenchymal stem cells