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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530071
Recruitment Status : Not yet recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
CHABiotech CO., Ltd

Study Description
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Brief Summary:
The objective of the study is to evaluate safety, tolerability, and efficacy of CordSTEM-DD in patients with chronic low back pain due to lumbar intervertebral disc degeneration

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Biological: CordSTEM-DD (0.7 x 10^7 cells) Biological: CordSTEM-DD (2.1 x 10^7 cells) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 28, 2020
Estimated Primary Completion Date : October 25, 2020
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: CordSTEM-DD(0.7x10^7 cells
Tissuefill+saline+CordSTEM-DD(0.7x10^7 cells)
 Biological: CordSTEM-DD (0.7 x 10^7 cells)
CordSTEM-DD (0.7 x 10^7 cells) on Stage 1
Experimental: CordSTEM-DD(2.1x10^7 cells)
Tissuefill+saline+CordSTEM-DD(2.1x10^7 cells)
 Biological: CordSTEM-DD (2.1 x 10^7 cells)
CordSTEM-DD (2.1 x 10^7 cells) on Stage 1


Outcome Measures
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Primary Outcome Measures :
  1. Number of treatment emergent adverse events during the study period [ Time Frame: 28 days on Stage 1 ]
  2. Number of treatment emergent adverse events during the study period [ Time Frame: 12 months on Stage 2 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or females at least 19 years and under 70 years of age
  2. Have chronic low back pain for at least 6 months and failed 6 months of conservative back pain care
  3. Screening period low back pain of at least 40mm on a 100mm VAS scale
  4. Screening period low back function of at least 30 on a 100-point ODI Questionnaire
  5. A modified Pfirrmann score of 3, 4, 5 or 6 on MRI at the index disc

Exclusion Criteria:

  1. NIH Clinical Guidelines Body Mass Index (BMI)>30 ㎏/m^2
  2. Osteoporosis, as defined by dual-energy X-ray absorptiometry (DEXA) scan. A DEXA T-score of ≤ -2.5 will exclude the subject
  3. An average baseline morphine equivalent dose (MED) of >75mg/day as determined by e-diary entries during the screening period
  4. Clinically significant nerve pain (e.g., chronic radiculopathy or neuropathy)
  5. If female, pregnancy, or lactation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530071


Contacts
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Contact: In-Bo Han +82 31 780 5000 hanib@cha.ac.kr

Sponsors and Collaborators
CHABiotech CO., Ltd
Investigators
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Principal Investigator: In-Bo Han CHA Bundang Medical Center
More Information
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Responsible Party: CHABiotech CO., Ltd
ClinicalTrials.gov Identifier: NCT04530071    
Other Study ID Numbers: CHA-CDD-101
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations