Degenerative Disc DiseasePhase 1NCT03955315
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Disc Degeneration
A Phase 1 study testing IDCT in people with Degenerative Disc Disease, run by DiscGenics, Inc. at 6 sites in Japan.
Trial summary
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and one sham control in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- IDCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 6 sitesJapan
- Study dates
- 23 May 2019to 28 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
Chiba University Hospital
Chuo-ku, Chiba, 260-8670
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Nagoya university hospital
Shōwaku, Nagoya, 466-8550
Osaka University Hospital
Suita, Osaka, 565-0871
Mie University Hospital
Tsu, Mie-ken, 514-8507
About this study
Official title: A Randomized, Double Blind, Sham-controlled, Multi-center Phase I / II Clinical Study to Assess the Safety and Efficacy of IDCT in Patients With Lumbar Degenerative Disc Disease
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and one sham control in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.
Read the detailed description
This is a Phase I, randomized, double-blind, sham-controlled, parallel-group, multi-center study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with one sham control group.
6 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26 and week 52. The subject will be assessed for safety and efficacy utilizing VAS, ODI and JOABPEQ questionnaires alongside radiographic evaluations. The study will have a 6 month follow-up and a 6 month extension period (total 1 year).
- Conditions
- Degenerative Disc Disease
- Being tested
- IDCT, Sham
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDCTBiological
Also called Injectable Disc Cell Therapy
Discogenic Cells + Sodium Hyaluronate Vehicle
ShamProcedure or surgery
Needle puncture under the muscular layer in front of the intervertebral disc
| Study group | Role | What they receive |
|---|---|---|
| High Dose IDCT | Experimental | Single intradiscal injection with High Dose IDCT (9M cells) Receives: Biological: IDCT |
| Low Dose IDCT | Experimental | Single intradiscal injection with Low Dose IDCT (3M cells). Receives: Biological: IDCT |
| Sham | Sham comparator | Sham needle puncture (outside disc) Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by number of Adverse Events
To evaluate the safety and tolerability of a single injection of IDCT in subjects with single-level, symptomatic early to moderate lumbar intervertebral disc degeneration as measured by the incidence of AEs and SAEs observed from Day 1 to week 52
Measured: 1 year
Efficacy (Pain): Visual Analogue Scale (VAS)
Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable
Measured: 6 months
Secondary outcomes (2)
Disability
Evaluate the effect of IDCT on disability as measured by the Oswestry Disability Index (ODI). Score of 0%: no disability, score of 100%: severely disabled
Measured: 1 year
Efficacy (Pain): JOABPEQ
Evaluate the effect of IDCT on pain as measured by JOABPEQ. The range of the score for each domain is from 0 to 100, with higher scores indicating a better condition.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start23 May 2019
- Primary completion1 Feb 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiscGenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955315
- Sponsor's protocol ID
- DGX-J01
- Status last verified
- Nov 2022
- First submitted
- 14 May 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silverman LI, Dulatova G, Tandeski T, Erickson IE, Lundell B, Toplon D, Wolff T, Howard A, Chintalacharuvu S, Foley KT. In vitro and in vivo evaluation of discogenic cells, an investigational cell therapy for disc degeneration. Spine J. 2020 Jan;20(1):138-149. doi: 10.1016/j.spinee.2019.08.006. Epub 2019 Aug 20.
PubMed 31442616
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Sham-controlled, Multi-center Phase I / II Clinical Study to Assess the Safety and Efficacy of IDCT in Patients With Lumbar Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT03955315
- Acronym / sponsor ID
- DGX-J01
- Conditions
- Degenerative Disc Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- DiscGenics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and one sham control in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.
Detailed description
This is a Phase I, randomized, double-blind, sham-controlled, parallel-group, multi-center study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with one sham control group.
6 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26 and week 52. The subject will be assessed for safety and efficacy utilizing VAS, ODI and JOABPEQ questionnaires alongside radiographic evaluations. The study will have a 6 month follow-up and a 6 month extension period (total 1 year).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose IDCT | Experimental | Biological: IDCTSingle intradiscal injection with High Dose IDCT (9M cells) |
| Low Dose IDCT | Experimental | Biological: IDCTSingle intradiscal injection with Low Dose IDCT (3M cells). |
| Sham | Sham comparator | Procedure: ShamSham needle puncture (outside disc) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDCTAlso: Injectable Disc Cell TherapyDiscogenic Cells + Sodium Hyaluronate Vehicle | Biological | High Dose IDCT, Low Dose IDCT |
| ShamNeedle puncture under the muscular layer in front of the intervertebral disc | Procedure or surgery | Sham |
Primary outcome
Safety as measured by number of Adverse Events
Time frame: 1 year
To evaluate the safety and tolerability of a single injection of IDCT in subjects with single-level, symptomatic early to moderate lumbar intervertebral disc degeneration as measured by the incidence of AEs and SAEs observed from Day 1 to week 52
Efficacy (Pain): Visual Analogue Scale (VAS)
Time frame: 6 months
Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable
2 secondary outcomes
Disability
Time frame: 1 year
Efficacy (Pain): JOABPEQ
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 31442616Silverman LI, Dulatova G, Tandeski T, Erickson IE, Lundell B, Toplon D, Wolff T, Howard A, Chintalacharuvu S, Foley KT. In vitro and in vivo evaluation of discogenic cells, an investigational cell therapy for disc degeneration. Spine J. 2020 Jan;20(1):138-149. doi: 10.1016/j.spinee.2019.08.006. Epub 2019 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDCT in people with Degenerative Disc Disease, run by DiscGenics, Inc. at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by number of Adverse Events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.