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