Degenerative Disc DiseasePhase 1NCT03347708
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
A Phase 1 study testing IDCT, Saline Solution and Sodium Hyaluronate in people with Degenerative Disc Disease, run by DiscGenics, Inc. at 14 sites in United States.
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 two controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar… 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, Saline Solution and Sodium Hyaluronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 14 sitesUnited States
- Study dates
- 26 Feb 2018to 10 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 and 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.
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- Clinical suspicion of facet pain as primary pain generator.
- 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204
Orthopedic Center of St. Louis
Chesterfield, Missouri, 63017
Physicians' Research Options, LLC
Draper, Utah, 84020
Otrimed
Edgewood, Kentucky, 41017
Clinical Investigations, LLC
Edmond, Oklahoma, 73013
University of Southern California
Los Angeles, California, 90033
Semmes Murphey
Memphis, Tennessee, 38120
Ainsworth Institute of Pain Management
New York, New York, 10022
Virginia iSpine
Richmond, Virginia, 23235
UC San Diego CIRM Alpha Stem Cell Clinic
San Diego, California, 92037
Source Healthcare
Santa Monica, California, 90403
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
About this study
Official title: A Prospective, Randomized, Double-Blinded, Vehicle- and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single-Level, Symptomatic Lumbar Intervertebral Disc Degeneration
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 two controls (saline, Sodium Hyaluronate vehicle) 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, first-in-human, randomized, double-blind, vehicle and placebo-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 two control groups (saline, Sodium Hyaluronate).
8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 52, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have a 1 year follow-up and a 1 year extension period (total 2 years).
- Conditions
- Degenerative Disc Disease
- Being tested
- IDCT, Saline Solution, Sodium Hyaluronate
- Keywords
- Lumbar disc degeneration, Low back pain, Intervertebral disc degeneration
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDCTBiological
Also called Progenitor Cells, Stem Cells, Allogeneic Cell Therapy
Discogenic Cells + Sodium Hyaluronate Vehicle
Saline SolutionDrug
Also called Saline injection, Placebo control
Sodium Chloride Solution
Sodium HyaluronateDrug
Also called Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control
Sodium Hyaluronate Vehicle
| 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 |
| Saline | Placebo comparator | Single intradiscal injection with saline solution. Receives: Drug: Saline Solution |
| Sodium Hyaluronate Vehicle | Placebo comparator | Single intradiscal injection with Sodium Hyaluronate Vehicle. Receives: Drug: Sodium Hyaluronate |
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 grade 2 or greater AEs and SAEs observed from Day 1 to week 104
Measured: 2 Years
Efficacy (Pain)
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: 1 Year
Secondary outcomes (1)
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: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start26 Feb 2018
- Primary completion1 Feb 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiscGenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347708
- Sponsor's protocol ID
- DGX-A01
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2017
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gornet MF, Beall DP, Davis TT, Coric D, LaBagnara M, Krull A, DePalma MJ, Hsieh PC, Mallempati S, Schranck FW, Kelly C, Foley KT. Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration-Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial. Int J Spine Surg. 2024 Jul 4;18(3):237-248. doi: 10.14444/8609.
PubMed 38925869Silverman 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blinded, Vehicle- and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single-Level, Symptomatic Lumbar Intervertebral Disc Degeneration
- ClinicalTrials.gov ID
- NCT03347708
- Acronym / sponsor ID
- DGX-A01
- Conditions
- Degenerative Disc Disease
- Keywords
- Lumbar disc degeneration, Low back pain, Intervertebral disc degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DiscGenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 20 Nov 2017 (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 two controls (saline, Sodium Hyaluronate vehicle) 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, first-in-human, randomized, double-blind, vehicle and placebo-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 two control groups (saline, Sodium Hyaluronate).
8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 52, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have a 1 year follow-up and a 1 year extension period (total 2 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| 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). |
| Saline | Placebo comparator | Drug: Saline SolutionSingle intradiscal injection with saline solution. |
| Sodium Hyaluronate Vehicle | Placebo comparator | Drug: Sodium HyaluronateSingle intradiscal injection with Sodium Hyaluronate Vehicle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 and ODI score of 30 to 90.
Key exclusion criteria (9 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: Progenitor Cells, Stem Cells, Allogeneic Cell TherapyDiscogenic Cells + Sodium Hyaluronate Vehicle | Biological | High Dose IDCT, Low Dose IDCT |
| Saline SolutionAlso: Saline injection, Placebo controlSodium Chloride Solution | Drug | Saline |
| Sodium HyaluronateAlso: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle controlSodium Hyaluronate Vehicle | Drug | Sodium Hyaluronate Vehicle |
Primary outcome
Safety as measured by number of Adverse Events
Time frame: 2 Years
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 grade 2 or greater AEs and SAEs observed from Day 1 to week 104
Efficacy (Pain)
Time frame: 1 Year
Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable.
1 secondary outcome
Disability
Time frame: 2 Years
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 25 Jan 2023.
- Derived from this study: PubMed 38925869Gornet MF, Beall DP, Davis TT, Coric D, LaBagnara M, Krull A, DePalma MJ, Hsieh PC, Mallempati S, Schranck FW, Kelly C, Foley KT. Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration-Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial. Int J Spine Surg. 2024 Jul 4;18(3):237-248. doi: 10.14444/8609.
- 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.
- Related InfoLink provided by the sponsor.
- 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.
14 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, Saline Solution and Sodium Hyaluronate in people with Degenerative Disc Disease, run by DiscGenics, Inc. at 14 sites in United States.
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 3 inclusion and 9 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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: 2 Years). 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 NCT03347708, which also lists 2 linked publications.
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 25 Jan 2023.