Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain

NCT04530071 | Completed Phase 1

• 1 other identifier: CHA-CDD-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CordSTEM-DD, an allogeneic umbilical cord-derived mesenchymal stem cell, as a cell-therapeutic drug in patients with chronic low back pain due to lumbar intervertebral disc degeneration.

Conditions

Chronic Low-back Pain; Disc Degeneration

Keywords

Stem Cell therapy; Cell therapy; Disc Degeneration; Back pain

Outcome Measures

Primary Outcomes (2)

• Number of treatment emergent adverse events during the study period

  28 days on Stage 1

• Number of treatment emergent adverse events during the study period

  12 months on Stage 2

Study Arms (3)

CordSTEM-DD(0.7x10^7 cells)

EXPERIMENTAL

HA+saline+CordSTEM-DD(0.7x10\^7 cells)

Biological: CordSTEM-DD (0.7 x 10^7 cells)

CordSTEM-DD(2.1x10^7 cells)

EXPERIMENTAL

HA+saline+CordSTEM-DD(2.1x10\^7 cells)

Biological: CordSTEM-DD (2.1 x 10^7 cells)

Control group

PLACEBO COMPARATOR

HA + saline + placebo comparator

Biological: Placebo

Interventions

CordSTEM-DD (0.7 x 10^7 cells) BIOLOGICAL

CordSTEM-DD (0.7 x 10\^7 cells)

CordSTEM-DD(0.7x10^7 cells)

CordSTEM-DD (2.1 x 10^7 cells) BIOLOGICAL

CordSTEM-DD (2.1 x 10\^7 cells)

CordSTEM-DD(2.1x10^7 cells)

Placebo BIOLOGICAL

HA + saline + placebo comparator

Control group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females aged ≥ 19 years and \< 70 years
• Have low back or hip pain that has lasted ≥ 6 months at the time of screening and do not respond to conservative therapy\* given for ≥ 3 months
• \* Conservative therapy: Rest at an early stage, drug treatment (e.g., anti-inflammatory drugs, analgesics, anesthetics, narcotic analgesics, muscle relaxants), massage, acupuncture, chiropractic treatment, posture correction, home lumbar exercise programs, etc.
• The Oswestry Disability Index (ODI) of 30% or greater and below 90% at screening
• The Visual Analogue Scale (VAS) score for pain in the lumbar spine of ≥ 40 mm and ≤ 90 mm in the last 3 months prior to screening
• The magnetic resonance imaging (MRI) grade 3 to 6 between lumbar vertebra 1 and sacral vertebra 1 according to the modified Pfirrmann classification method at screening
• One pain-causing degenerative lumbar disc identified at screening. However, degenerative lumbar discs causing pain are identified by discography.
• Those who provide written consent to comply with the precautions after they or their representatives voluntarily decide to participate subsequent to listening to a detailed explanation of this clinical study and understanding it completely

You may not qualify if:

• Body mass index (BMI) of 30 ㎏/m2 or greater
• Those who require surgery because they have symptoms of nerve compression due to severe lumbar spinal stenosis or lumbar herniated nucleus pulposus
• Those with spinal instability, spondylitis, or vertebral fractures
• Severe degenerative changes in the intervertebral disc leading to a 30% or more decrease in the height of the intervertebral disc
• Those who have modic type 3 changes on MRI
• Those with severe osteoporosis
• \* An average T score of -2.5 or less in the lumbar bone density test (DEXA, Dual-Energy X-ray Absorptiometry)
• Those who have undergone procedures (electrocoagulation of the intervertebral disc, etc.) and surgery such as discectomy on the disc to be administered with the investigational product However, in the case of electrocoagulation, enrollment is allowed if the procedure was performed 3 months prior to the administration of the investigational product on the annulus fibrosus, not on the nucleus pulposus.
• Those who took at least 75 mg/day of morphine equivalent dose (MED) during the screening period
• Those who have full-thickness annular tears (modified Dallas diagram scale grade 5) at index level when a contrast medium is administered to annulus fibrosus (AF)
• Those with clinically significant neuralgia (e.g., chronic radiculopathy) or neuropathy
• Those with clinically significant sacroiliac joint pain
• Those who have compressive pathology due to stenosis or disc extrusion confirmed by MRI, and have clinical symptoms of leg pain with VAS of 40 mm or more, or a neurological deficit confirmed in a neurological examination
• Those with intermittent neurogenic claudication due to central vertebral canal stenosis
• Those with lumbar spondylitis or ankylosing spondylitis caused by autoimmune diseases, etc.

Sponsors & Collaborators

• CHABiotech CO., Ltd: lead
• Seoul CRO Co., Ltd.: collaborator

Study Sites (1)

CHA Bundand Medical Center

Seongnam-si, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Bo Han

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blinding will be used to prevent subjective biases of the subjects and the investigator from affecting the study results. Subject assignment group will be disclosed only to the unblinded sub-investigator or unblinded study coordinator and unblinded investigator designated as a person responsible for IP management and procedures.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 28, 2020
• Study Start: September 21, 2020
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)