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

• ClinicalTrials.gov Identifier: NCT03347708
• Recruitment Status: Recruiting
• First Posted: November 20, 2017
• Last Update Posted: October 1, 2019
• Sponsor: DiscGenics, Inc.
• Information provided by (Responsible Party): DiscGenics, Inc.

Tracking Information

• First Submitted Date: November 1, 2017
• First Posted Date: November 20, 2017
• Last Update Posted Date: October 1, 2019
• Actual Study Start Date: February 26, 2018
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 20, 2017)

• 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.

Original Primary Outcome Measures (submitted: November 15, 2017)

• 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).

• Change History: Complete list of historical versions of study NCT03347708 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 20, 2017)

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

Original Secondary Outcome Measures (submitted: November 15, 2017)

Disability [ Time Frame: 2 Years ]

Evaluate the effect of IDCT on disability as measured by the Oswestry Disability Index (ODI).

Current Other Pre-specified Outcome Measures (submitted: November 15, 2017)

Exploratory [ Time Frame: 2 Years ]

Imaging parameters will be evaluated via radiological evaluations

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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).

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Double Blind

Primary Purpose: Treatment

• Condition: Degenerative Disc Disease

Intervention

• Biological: IDCT
  Discogenic Cells + Sodium Hyaluronate Vehicle
  Other Name: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy
• Drug: Saline Solution
  Sodium Chloride Solution
  Other Name: Saline injection, Placebo control
• Drug: Sodium Hyaluronate
  Sodium Hyaluronate Vehicle
  Other Name: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control

Study Arms

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

• 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. 2019 Aug 20. pii: S1529-9430(19)30935-0. doi: 10.1016/j.spinee.2019.08.006. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 15, 2017): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2021
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Katie Simpson; 8016644176; katie@discgenics.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03347708
• Other Study ID Numbers: DGX-A01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: DiscGenics, Inc.
• Study Sponsor: DiscGenics, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: DiscGenics, Inc.
• Verification Date: September 2019