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

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IDCT
Saline Solution
Sodium Hyaluronate
Sponsored by
DiscGenics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Lumbar disc degeneration, Low back pain, Intervertebral disc degeneration

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subject must have:

  1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.
  2. Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.
  3. 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:

  1. Symptomatic involvement of more than one lumbar disc.
  2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.
  3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.
  4. Evidence of dynamic instability on lumbar flexion-extension radiographs.
  5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.
  6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.
  7. Clinical suspicion of facet pain as primary pain generator.
  8. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.
  9. Patients who are deemed unsuitable for clinical study participation by the investigator.

Sites / Locations

  • Alabama Clinical Therapeutics, LLC
  • University of Southern California
  • UC San Diego CIRM Alpha Stem Cell Clinic
  • Source Healthcare
  • Otrimed
  • Spine Institute of Louisiana
  • Orthopedic Center of St. Louis
  • Ainsworth Institute of Pain Management
  • Carolina Neurosurgery & Spine Associates
  • Clinical Investigations, LLC
  • Clinical Trials of South Carolina
  • Semmes Murphey
  • Physicians' Research Options, LLC
  • Virginia iSpine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

High Dose IDCT

Low Dose IDCT

Saline

Sodium Hyaluronate Vehicle

Arm Description

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

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

Single intradiscal injection with saline solution.

Single intradiscal injection with Sodium Hyaluronate Vehicle.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2017
Last Updated
January 23, 2023
Sponsor
DiscGenics, Inc.
Collaborators
CTI Clinical Trial and Consulting Services
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1. Study Identification

Unique Protocol Identification Number
NCT03347708
Brief Title
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DiscGenics, Inc.
Collaborators
CTI Clinical Trial and Consulting Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Lumbar disc degeneration, Low back pain, Intervertebral disc degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose IDCT
Arm Type
Experimental
Arm Description
Single intradiscal injection with High Dose IDCT (9M cells).
Arm Title
Low Dose IDCT
Arm Type
Experimental
Arm Description
Single intradiscal injection with Low Dose IDCT (3M cells).
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Single intradiscal injection with saline solution.
Arm Title
Sodium Hyaluronate Vehicle
Arm Type
Placebo Comparator
Arm Description
Single intradiscal injection with Sodium Hyaluronate Vehicle.
Intervention Type
Biological
Intervention Name(s)
IDCT
Other Intervention Name(s)
Progenitor Cells, Stem Cells, Allogeneic Cell Therapy
Intervention Description
Discogenic Cells + Sodium Hyaluronate Vehicle
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Other Intervention Name(s)
Saline injection, Placebo control
Intervention Description
Sodium Chloride Solution
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Other Intervention Name(s)
Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control
Intervention Description
Sodium Hyaluronate Vehicle
Primary Outcome Measure Information:
Title
Safety as measured by number of Adverse Events
Description
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
Title
Efficacy (Pain)
Description
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 Outcome Measure Information:
Title
Disability
Description
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 Pre-specified Outcome Measures:
Title
Exploratory
Description
Imaging parameters will be evaluated via radiological evaluations
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
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.
Facility Information:
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UC San Diego CIRM Alpha Stem Cell Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Source Healthcare
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Otrimed
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Orthopedic Center of St. Louis
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Ainsworth Institute of Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Carolina Neurosurgery & Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Clinical Investigations, LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Semmes Murphey
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Physicians' Research Options, LLC
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Virginia iSpine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31442616
Citation
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.
Results Reference
derived
Links:
URL
http://www.discgenics.com
Description
Related Info

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

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