Could a single injection fix your aching back? new trial tests disc repair cells
NCT ID NCT03955315
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested an experimental treatment called IDCT (injectable disc cell therapy) in 38 people with chronic low back pain due to degenerative disc disease. Participants received either a low or high dose of the cell therapy or a sham procedure. The goal was to check safety and see if the treatment reduces pain and disability. Results are still being analyzed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Injectable disc cell therapy (discogenic cells mixed with sodium hyaluronate)
- What this could lead to
- If successful, this could lead to a non-surgical treatment that repairs damaged spinal discs and reduces chronic low back pain.
- What could go wrong
- This is an early phase I/II trial with only 38 participants, so results are preliminary. The treatment may not work better than a sham procedure, and there could be unknown side effects.
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
-
38 people
The number who actually took part.
- Started
-
May 2019
- Finished
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Nov 2022
- Lead sponsor
-
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
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
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: * Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7. * Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care. * Low-back pain of 40 to 90 mm on the VAS * ODI score of 30 to 90. Exclusion Criteria: * Symptomatic involvement of more than one lumbar disc. * Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, Cauda Equine syndrome, etc. * Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc. * Evidence of dynamic instability on lumbar flexion-extension radiographs. * Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc. * Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology. * Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection. * Patients who are deemed unsuitable for clinical study participation by the investigator.
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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.
Contacts and locations
Locations
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Chiba University Hospital
Chuo-ku, Chiba, 260-8670, Japan
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Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
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Nagoya university hospital
Shōwaku, Nagoya, 466-8550, Japan
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Osaka University Hospital
Suita, Osaka, 565-0871, Japan
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Tokai University Hospital
Isehara, Kanagawa, 259-1193, Japan
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University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
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