- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04530071
Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain
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
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: In-Bo Han
- Phone Number: +82 31 780 5000
- Email: hanib@cha.ac.kr
Study Locations
-
-
-
Seongnam-si, Korea, Republic of
- CHA Bundand Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CordSTEM-DD(0.7x10^7 cells)
HA+saline+CordSTEM-DD(0.7x10^7 cells)
|
CordSTEM-DD (0.7 x 10^7 cells)
|
Experimental: CordSTEM-DD(2.1x10^7 cells)
HA+saline+CordSTEM-DD(2.1x10^7 cells)
|
CordSTEM-DD (2.1 x 10^7 cells)
|
Placebo Comparator: Control group
HA + saline + placebo comparator
|
HA + saline + placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of treatment emergent adverse events during the study period
Time Frame: 28 days on Stage 1
|
28 days on Stage 1
|
Number of treatment emergent adverse events during the study period
Time Frame: 12 months on Stage 2
|
12 months on Stage 2
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: In-Bo Han, CHA Bundang Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHA-CDD-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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