NCT03347708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_1

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

January 25, 2023

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

November 1, 2017

Last Update Submit

January 23, 2023

Conditions

Degenerative Disc Disease

Keywords

Lumbar disc degenerationLow back painIntervertebral disc degeneration

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    1 Year

Secondary Outcomes (1)

  • Disability

    2 Years

Other Outcomes (1)

  • Exploratory

    2 Years

Study Arms (4)

High Dose IDCT

EXPERIMENTAL

Single intradiscal injection with High Dose IDCT (9M cells).

Biological: IDCT

Low Dose IDCT

EXPERIMENTAL

Single intradiscal injection with Low Dose IDCT (3M cells).

Biological: IDCT

Saline

PLACEBO COMPARATOR

Single intradiscal injection with saline solution.

Drug: Saline Solution

Sodium Hyaluronate Vehicle

PLACEBO COMPARATOR

Single intradiscal injection with Sodium Hyaluronate Vehicle.

Drug: Sodium Hyaluronate

Interventions

IDCTBIOLOGICAL

Discogenic Cells + Sodium Hyaluronate Vehicle

Also known as: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy
High Dose IDCTLow Dose IDCT
Saline SolutionDRUG

Sodium Chloride Solution

Also known as: Saline injection, Placebo control
Saline
Sodium HyaluronateDRUG

Sodium Hyaluronate Vehicle

Also known as: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control
Sodium Hyaluronate Vehicle

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

UC San Diego CIRM Alpha Stem Cell Clinic

San Diego, California, 92037, United States

Location

Source Healthcare

Santa Monica, California, 90403, United States

Location

Otrimed

Edgewood, Kentucky, 41017, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Orthopedic Center of St. Louis

Chesterfield, Missouri, 63017, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73013, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Semmes Murphey

Memphis, Tennessee, 38120, United States

Location

Physicians' Research Options, LLC

Draper, Utah, 84020, United States

Location

Virginia iSpine

Richmond, Virginia, 23235, United States

Location

Related Publications (2)

  • 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.

    PMID: 38925869DERIVED

  • 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.

    PMID: 31442616DERIVED

Related Links

MeSH Terms

Conditions

Intervertebral Disc DegenerationLow Back Pain

Interventions

Saline SolutionSodium ChlorideHyaluronic Acid

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 20, 2017

Study Start

February 26, 2018

Primary Completion

February 1, 2022

Study Completion

November 10, 2022

Last Updated

January 25, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(14)