Could a single injection fix your aching back?
NCT ID NCT06144970
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This early-stage trial tests a new cell-based injection called TG-C for people with long-term lower back pain due to degenerative disc disease. 24 adults aged 22 to 70 will receive either a high, mid, or low dose of TG-C injected into the spinal disc, or a sham (fake) injection. The main goal is to check safety over 24 months, with pain levels also tracked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TG-C (a mixture of cells injected into the spinal disc)
- What this could lead to
- If safe and effective, this could point toward a non-surgical treatment for chronic back pain caused by worn-out discs.
- What could go wrong
- This is a very early Phase 1 trial with only 24 people, so it is primarily checking safety, not whether it works. The treatment involves injecting cells into the spine, which carries risks like infection or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Between the ages of \>= 22 and \<= 70 * Provides written informed consent before undergoing any study specific procedures * Chronic lower back pain for at least 6 months. Back pain twice as great as leg pain measured using NRS * VAS between \>= 40 and \<= 90 * ODI Index \>30 and \<= 80 * Inadequate response to at least one medication (e.g., NSAID, acetaminophen, muscle relaxant) and some form of formal physical therapy over a period of at least 6 months, within 6-9 months of screening. * Diagnosis of DDD from L1 to S1, confirmed by patient history and radiographic studies * Modified Pfirrmann score of 3-7 on MRI * With or without contained disc herniations of \<3 mm protrusion * If more than 1 degenerative disc is identified. PD must be performed 30 days prior and ensure only one level is the pain generator * BMI \>15 and \< 30 kg/m2 * Use birth control Exclusion Criteria: * Co-morbid medical condition of the spine or upper extremities * Grade 2 or higher spondylolisthesis and type III Modic changes around target disc * Suspicion of full thickness annular tear at disc * History of endocrine or metabolic disorder * Rheumatoid or psoriatic arthritis * Compressive pathology due to stenosis or herniated or sequestered discs * Symptomatic involvement of more than one lumber disc * Intact disc bulge/protrusion at \>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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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