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Chronic Low-back PainPhase 1/2NCT04530071

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

A Phase 1/2 study testing CordSTEM-DD (0.7 x 10^7 cells) and CordSTEM-DD (2.1 x 10^7 cells) in people with Chronic Low-back Pain and Disc Degeneration, run by CHABiotech CO., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 69 years
Conditions the study is for
Chronic Low-back Pain, Disc Degeneration
What is being tested?
CordSTEM-DD (0.7 x 10^7 cells) and CordSTEM-DD (2.1 x 10^7 cells)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteSouth Korea
Study dates
21 Sep 2020to 17 Apr 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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.
  • Those with facet joint pain confirmed through a diagnostic medical branch block
  • Those who have received an injection of a drug containing steroids into the disc, except for the following drugs, within 3 weeks of the administration of the investigational product (1) Contrast medium (discography or other diagnostic injection) (2) Non-steroidal anti-inflammatory drugs (NSAIDs) (3) Nerve-blocking local anesthetics: e.g., lidocaine, bupivacaine (4) Antibiotics (5) Normal saline (saline)
  • Those who have a history of malignancy within 5 years of screening
  • Those taking systemic immunosuppressants
  • Those who have received biological treatments such as proteins and antibody treatments for the treatment of degenerative disc disease (DDD)
  • Those who have received intravertebral cell-therapeutic drugs or platelet rich plasma (PRP) therapy (However, enrollment is allowed if stem cell therapy was administered by a route other than the intervertebral disc and ≥ 5 years have passed)
  • Those who may affect this clinical study due to serious medical disease [uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled active infection or tuberculosis, cirrhosis of the liver, kidney failure, tumors, etc.]
  • Those with a history of allergy to protein products (bovine serum), antibiotics (gentamicin), DMSO, and hyaluronic acid (HA) required for the manufacture of cell-therapeutic drugs
  • Those who have a psychiatric history or are being treated, and the investigator determines that it is difficult to proceed with the clinical study
  • Those who exceed 30 points on the Beck Depression Inventory (BDI)
  • Those who cannot understand the purpose, method, etc. of this clinical study due to drug or alcohol addiction
  • Those who participated in other clinical studies within 6 months prior to participation in this clinical study
  • Pregnant or breastfeeding women
  • Male or female patients of childbearing potential who do not agree to use medically acceptable methods of contraception* during the clinical study period
  • Medically acceptable methods of contraception: Condoms, oral contraceptives for at least 3 months, injectable contraceptive procedure performed 3 months ago, use of injectable or implantable contraceptives, intrauterine contraceptive devices, etc.
  • Those who are ineligible for participation in the clinical study in the judgment of the principal investigator or sub-investigator due to other ethical reasons or reasons that may affect the results of the clinical study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundand Medical Center

    Seongnam-si

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1/2a, Multi-center Clinical Trial for Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain Due to Lumbar Intervertebral Disc Degeneration

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.

Read the detailed description

This study is designed as a randomized, double-blind, placebo-controlled, single-dose, phase 1/2a, multi-center study to evaluate the safety, tolerability, and efficacy of the treatment with CordSTEM-DD, an allogeneic umbilical cord-derived mesenchymal stem cell, in patients with chronic low back pain due to lumbar intervertebral disc degeneration.

During the study period, subjects will have a total of 8 visits: Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12, in addition to screening and baseline visits.

The primary objective will include assessment of safety and tolerability for 12 months after the administration of the study drug. Safety will be assessed based on the results of adverse events, confirmation of malignancy, all deaths, laboratory tests, and physical examinations/vital signs. As the secondary objective, efficacy will be assessed by identifying the Visual Analogue Scale (VAS), Oswestry Disability Index (ODI ), treatment success rate, The 36-Item Short Form Health Survey (SF-36) score, and change on lumbar MRI.

This clinical study consists of Stage I and Stage II, and the composition of the study group and the control group in each stage and the number of subjects to be enrolled are as follows:

[Stage I]

  • Group 1 (3 subjects): Hyaluronic Acid (HA) + saline + study drug (0.7 × 10^7 cells CordSTEM-DD)
  • Group 2 (3 subjects): HA + saline + study drug (2.1 × 10^7 cells CordSTEM-DD) [Stage II] After confirming the safety of the administered dose of the investigational product in Stage I, an additional 30 subjects will be recruited and randomized.
  • Control group (10 subjects): HA + saline + comparator
  • Group 1 (10 subjects): HA + saline + study drug (0.7 × 10^7 cells CordSTEM-DD)
  • Group 2 (10 subjects): HA + saline + study drug (2.1 × 10^7 cells CordSTEM-DD)
Being tested
CordSTEM-DD (0.7 x 10^7 cells), CordSTEM-DD (2.1 x 10^7 cells), Placebo
Keywords
Stem Cell therapy, Cell therapy, Disc Degeneration, Back pain
Medical subject headings
Intervertebral Disc Degeneration, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    CordSTEM-DD (0.7 x 10^7 cells)

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

    CordSTEM-DD (2.1 x 10^7 cells)

  • PlaceboBiological

    HA + saline + placebo comparator

Study groups in NCT04530071
Study groupRoleWhat they receive
CordSTEM-DD(0.7x10^7 cells)ExperimentalHA+saline+CordSTEM-DD(0.7x10^7 cells)
Receives: Biological: CordSTEM-DD (0.7 x 10^7 cells)
CordSTEM-DD(2.1x10^7 cells)ExperimentalHA+saline+CordSTEM-DD(2.1x10^7 cells)
Receives: Biological: CordSTEM-DD (2.1 x 10^7 cells)
Control groupPlacebo comparatorHA + saline + placebo comparator
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent adverse events during the study period

    Measured: 28 days on Stage 1

  2. Number of treatment emergent adverse events during the study period

    Measured: 12 months on Stage 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start21 Sep 2020
  3. Primary completion17 Apr 2023
  4. Study completion17 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530071
Sponsor's protocol ID
CHA-CDD-101
Status last verified
Aug 2023
First submitted
19 Aug 2020
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CordSTEM-DD (0.7 x 10^7 cells) and CordSTEM-DD (2.1 x 10^7 cells) in people with Chronic Low-back Pain and Disc Degeneration, run by CHABiotech CO., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment emergent adverse events during the study period (time frame: 28 days on Stage 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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