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

NCT04530071 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

  • Chronic Low-back Pain
  • Disc Degeneration

Interventions

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

Sponsors & Collaborators

  • Seoul CRO Co., Ltd.

    collaborator UNKNOWN

  • CHABiotech CO., Ltd

    lead INDUSTRY

Principal Investigators

  • In-Bo Han · CHA Bundang Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2023-04-17
Completion
2023-04-17

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530071 on ClinicalTrials.gov