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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: CHABiotech CO., Ltd · Industry
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Chronic Low-back Pain
• Disc Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	CordSTEM-DD (0.7 x 10^7 cells)	CordSTEM-DD (0.7 x 10\^7 cells)
BIOLOGICAL	CordSTEM-DD (2.1 x 10^7 cells)	CordSTEM-DD (2.1 x 10\^7 cells)
BIOLOGICAL	Placebo	HA + saline + placebo comparator

Timeline

• Start date: 2020-09-21
• Primary completion: 2023-04-17
• Completion: 2023-04-17
• First posted: 2020-08-28
• Last updated: 2023-08-30

Locations

1 site across 1 country: South Korea