Chronic low back pain nucleus pulposus

Phase 1

• Conditions: chronic low back pain.; Lumbar and other intervertebral disc disorders with radiculopathy; M51.1

• Registration Number: IRCT20080728001031N35
• Lead Sponsor: Royan Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Age between 18 and 65 years
Of both sexes
Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
The fibrous ring is able to hold the injected cell based on the discography performed. This means that stage of the disease must be 2,3 or 4 and stage 5 cannot be included in the study.
Reduction of intervertebral disc height by 50% or more based on radiography.
Do not have a vertebral infection.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Have no uncontrolled chronic underlying disease that is prohibited for treatment.
Do not be pregnant or breastfeeding women.
Not positive and transmissible viral infection.

Exclusion Criteria

infection signs or positive serology for HIV, hepatitis and syphilis
allergy to gentanicin, or to bovine, cattle or horse serum
congenital or acquired disease leading to spine deformities that may upset cell application
spinal segmental instability, spinal canal stenos, isthmus pathology, and other conditions that may compromise the study
modic 3 changes on MRI images
overweight with body mass index greater than 30.5
neoplasia
immunosuppression
participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
other conditions that may, according to medical criteria, discourage participation in the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical examination. Timepoint: 1- Within one month after discharge every week. Method of measurement: 1- Within one month after discharge every week: Responsible: Specialist: Action plan: Clinical examination, examination of complications of surgery or aspiration.;Evaluation of complications of surgery or aspiration. Timepoint: 2-6 weeks after injection. Method of measurement: 2-6 weeks after injection: Responsible: Specialist: Action plan: Clinical examination, examination of complications of operation or aspiration.

Secondary Outcome Measures

Name	Time	Method
Clinical examination and evaluation of the safety. Timepoint: Three months after injection. Method of measurement: Three months after injection: Responsible: Physician specializing in measures: Evaluation of treatment safety by evaluating questionnaires for examination of complications and clinical examinations.;Blood and urine tests. Timepoint: 6 months after injection. Method of measurement: six months after injection: Responsible: Physician specializing in measures blood and urine tests.;The effect of treatment by MRI. Timepoint: one year after injection. Method of measurement: one year after injection: Responsible: specialist doctor Measurs assessment of the effectiveness of treatment by MRI.