Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03347708 |
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Recruitment Status :
Active, not recruiting
First Posted : November 20, 2017
Last Update Posted : March 4, 2020
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Sponsor:
DiscGenics, Inc.
Information provided by (Responsible Party):
DiscGenics, Inc.
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Brief 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 level from L3 to S1.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Degenerative Disc Disease | Biological: IDCT Drug: Saline Solution Drug: Sodium Hyaluronate | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | Double Blind |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 26, 2018 |
| Estimated Primary Completion Date : | April 2020 |
| Estimated Study Completion Date : | April 2021 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Intervertebral disc disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: High Dose IDCT
Single intradiscal injection with High Dose IDCT (9M cells).
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Biological: IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Other Name: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy |
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Experimental: Low Dose IDCT
Single intradiscal injection with Low Dose IDCT (3M cells).
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Biological: IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Other Name: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy |
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Placebo Comparator: Saline
Single intradiscal injection with saline solution.
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Drug: Saline Solution
Sodium Chloride Solution
Other Name: Saline injection, Placebo control |
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Placebo Comparator: Sodium Hyaluronate Vehicle
Single intradiscal injection with Sodium Hyaluronate Vehicle.
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Drug: Sodium Hyaluronate
Sodium Hyaluronate Vehicle
Other Name: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Disability [ Time Frame: 2 Years ]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
Other Outcome Measures:
- Exploratory [ Time Frame: 2 Years ]Imaging parameters will be evaluated via radiological evaluations
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: The subject must have:
- 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.
Exclusion Criteria: The subject is excluded if he/she has:
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347708
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics, LLC | |
| Birmingham, Alabama, United States, 35235 | |
| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| UC San Diego CIRM Alpha Stem Cell Clinic | |
| San Diego, California, United States, 92037 | |
| Source Healthcare | |
| Santa Monica, California, United States, 90403 | |
| United States, Kentucky | |
| Otrimed | |
| Edgewood, Kentucky, United States, 41017 | |
| United States, Louisiana | |
| Spine Institute of Louisiana | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Missouri | |
| Orthopedic Center of St. Louis | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, New York | |
| Ainsworth Institute of Pain Management | |
| New York, New York, United States, 10022 | |
| United States, North Carolina | |
| Carolina Neurosurgery & Spine Associates | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Oklahoma | |
| Clinical Investigations, LLC | |
| Edmond, Oklahoma, United States, 73013 | |
| United States, South Carolina | |
| Clinical Trials of South Carolina | |
| Charleston, South Carolina, United States, 29406 | |
| United States, Tennessee | |
| Semmes Murphey | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Utah | |
| Physicians' Research Options, LLC | |
| Draper, Utah, United States, 84020 | |
| United States, Virginia | |
| Virginia iSpine | |
| Richmond, Virginia, United States, 23235 | |
Sponsors and Collaborators
DiscGenics, Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | DiscGenics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03347708 |
| Other Study ID Numbers: |
DGX-A01 |
| First Posted: | November 20, 2017 Key Record Dates |
| Last Update Posted: | March 4, 2020 |
| Last Verified: | March 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by DiscGenics, Inc.:
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Lumbar disc degeneration Low back pain Intervertebral disc degeneration |
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases Pharmaceutical Solutions Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |