Safety and Efficacy Study of Matrilin-3 Pretreated Autologous Adipose Derived Mesenchymal Stem Cells Implantation in Chronic Low Back Pain Patients With Lumbar Intervertebral Disc Degeneration (MANT3_ASC)

To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration.

Study Overview

• Status: Enrolling by invitation
• Conditions: Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc
• Intervention / Treatment: Biological: administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3

• Study Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • CHA University, CHA Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients aged 19-70 years
• Among the subjects with low back pain, conventional conservative treatment is performed, but the back pain or hip pain persists for more than 3 months, and it is determined that the cause of the back pain is a degenerative disc (MRI checks for a degenerative disc)
• Has Oswestry Disability score(ODI) ≥ 30%
• Has Visual Analogue Scale(VAS) ≥ 4
• Between lumbar 1-sacral 1, Magnetic Resonance Imaging (MRI) grade according to the Pfirrmann classification is 3~4.
• Has one or two degenerative lumbar discs identified by MRI (Confirmation of low back pain due to disc through various nerve block procedures.)
• Consent was prepared for stem cell administration

Exclusion Criteria:

• Patient requiring surgery due to severe pain in lower extremities due to severe nerve compression due to severe lumbar stenosis or prolapse of lumbar nucleus.
• patient with spinal instability, spondylitis, or vertebral fracture
• type 3 Modic change is in an endplate
• Patient whose disc height has decreased by more than 1/2 due to severe disc degenerative change
• Patient with severe osteoporosis (The average value of the T score in the lumbar spine bone density test is -2.5 or less)
• has undergone surgery, such as disc resection, on the disc to which the cells will be administered
• Patient who received lumbar epidural steroid injection 3 weeks before cell administration
• Pregnant or lactating women

• Among female patients who are likely to become pregnant during the clinical trial, who do not use medically acceptable methods of contraception

  • medically acceptable methods of contraception: condom, Oral contraception lasting for at least 3 months, Has received an infusion pill before 3 months, using an injectable or implantable contraceptive, or installed an intrauterine contraceptive device
• has a history of psychiatry or who are currently undergoing treatment, who judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
• Patient with drug or alcohol addiction who cannot understand the purpose and method of this clinical trial
• Patient who participated in other clinical trials within 3 months prior to participation in the trial
• Patient who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, cirrhosis, kidney failure, tumors)
• Patient with a history of malignant tumors within the last 5 years
• has a history of administration of cell therapy products
• Other persons who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection	It will be considered safe and tolerated in the absence of the following: Grade 3 (NCI grading system) or higher adverse reactions related to cell products; Any evidence that the cells are contaminated with infectious substances; Any evidence that cells show tumorigenic potential	During Clinical Trial Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of the degree of pain improvement in VAS	on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain you can imagine	before and at 1 week, 1, 3, 6 months after stem cell injection
Confirmation of the degree of improvement in disability (ODI)	on a scale of 0 to 3, with 0 meaning no disability and 10 meaning severe disability	before stem cell injection and at 1 week, 1, 3, and 6 months after injection
Confirmation of increase in water content in the nucleus using MRI		before stem cell injection and at 1 and 6 month after injection

Collaborators and Investigators

• Sponsor: Inbo Han

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2021
• Primary Completion (ANTICIPATED): January 20, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (ACTUAL): August 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: 2018-10-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No