Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain
Condition: Chronic Low-back Pain; Disc Degeneration
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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)
    

Intervention name(s): CordSTEM-DD (0.7 x 10^7 cells); CordSTEM-DD (2.1 x 10^7 cells); Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): CordSTEM-DD (0.7 x 10^7 cells); CordSTEM-DD (2.1 x 10^7 cells); HA + saline + placebo comparator
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stem Cell therapy; Cell therapy; Disc Degeneration; Back pain