CompletedNCT03347708Updated Jan 25, 2023

Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration

A Phase 1 interventional study of IDCT and Saline Solution in Degenerative Disc Disease, sponsored by DiscGenics, Inc.. Completed at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by DiscGenics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Feb 2022, 4 years 9 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

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 studied

Degenerative Disc Disease

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Keywords

Lumbar disc degeneration
Low back pain
Intervertebral disc degeneration

In context

Intervertebral Disc Degeneration

462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

DiscGenics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility 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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Experimental
High Dose IDCT
Single intradiscal injection with High Dose IDCT (9M cells).
Biological: IDCT
Experimental
Low Dose IDCT
Single intradiscal injection with Low Dose IDCT (3M cells).
Biological: IDCT
Placebo comparator
Saline
Single intradiscal injection with saline solution.
Drug: Saline Solution
Placebo comparator
Sodium Hyaluronate Vehicle
Single intradiscal injection with Sodium Hyaluronate Vehicle.
Drug: Sodium Hyaluronate

Interventions

BiologicalIDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Also known as: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy
DrugSaline Solution
Sodium Chloride Solution
Also known as: Saline injection, Placebo control
DrugSodium Hyaluronate
Sodium Hyaluronate Vehicle
Also known as: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control

What researchers measure

Primary outcomes

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
Time frame: 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.
Time frame: 1 Year

Secondary outcomes

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
Time frame: 2 Years

Other outcomes

Exploratory
Imaging parameters will be evaluated via radiological evaluations
Time frame: 2 Years

Study locations

14 sites

Alabama Clinical Therapeutics, LLC
Birmingham, Alabama 35235, United States
University of Southern California
Los Angeles, California 90033, United States
UC San Diego CIRM Alpha Stem Cell Clinic
San Diego, California 92037, United States
Source Healthcare
Santa Monica, California 90403, United States
Otrimed
Edgewood, Kentucky 41017, United States
Spine Institute of Louisiana
Shreveport, Louisiana 71101, United States
Orthopedic Center of St. Louis
Chesterfield, Missouri 63017, United States
Ainsworth Institute of Pain Management
New York, New York 10022, United States
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina 28204, United States
Clinical Investigations, LLC
Edmond, Oklahoma 73013, United States
Clinical Trials of South Carolina
Charleston, South Carolina 29406, United States
Semmes Murphey
Memphis, Tennessee 38120, United States
Physicians' Research Options, LLC
Draper, Utah 84020, United States
Virginia iSpine
Richmond, Virginia 23235, United States

References and documents

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 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Feb 2022, 47 months.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 1, 2017
First posted: Nov 20, 2017
StartActual: Feb 26, 2018
Primary completionActual: Feb 1, 2022
CompletionActual: Nov 10, 2022
Last update: Jan 25, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03347708
Lead sponsor: DiscGenics, Inc.
Collaborators: CTI Clinical Trial and Consulting Services
Responsible party: Sponsor
First posted: Nov 20, 2017
Start date: Feb 26, 2018
Primary completion: Feb 1, 2022
Completion: Nov 10, 2022
Last update: Jan 25, 2023

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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