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Not Yet Recruiting NCT06144970

Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease

Conditions: Degenerative Disc Disease

Sex: All
Ages: 22 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: Kolon TissueGene, Inc.

Summary

The goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease. Participants will be administered a single intradiscal injection or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months.

Eligibility Criteria

Inclusion Criteria: * Between the ages of \>= 22 and \= 40 and \30 and \3 mm * Lumbar intervertebral foraminal stenosis * Previous surgery at the target disc level * Epidural or facet joint steroid, platelet rich plasma (PRP) or bone marrow concentrate (BMC) injections, or radio frequency ablation (RFA), within 6 months prior to baseline. * Pregnant * Presence of ferromagnetic implants * Involved in current or pending spinal litigations * Care is provided under a Worker's Compensation claim * Physical or mental conditions * 3 or more of the 5 Waddell signs * Positive screen for HIV * Immediate family member of other participating patients * Participated within 3 months or is concurrently enrolled in non-interventional research * Transient or has a history of any substance use disorder * Currently incarcerated * Investigator site personnel or immediate family or sponsor employee * On chronic anti-coagulation therapy or have confirmed coagulopathy * Tested positive on RCR testing at screening

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06144970). StuddyBuddy aggregates publicly available trial information.