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

• ClinicalTrials.gov Identifier: NCT03955315
• Recruitment Status: Unknown
• First Posted: May 20, 2019
• Last Update Posted: August 8, 2019
• Sponsor: DiscGenics, Inc.
• Information provided by (Responsible Party): DiscGenics, Inc.

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 one sham control 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; Procedure: Sham	Phase 1; Phase 2

Detailed Description:

This is a Phase I/II, randomized, double-blind, sham-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 one sham control group.

6 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26 and week 52. The subject will be assessed for safety and efficacy utilizing VAS, ODI and JOABPEQ questionnaires alongside radiographic evaluations. The study will have a 6 month follow-up and a 6 month extension period (total 1 year).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Sham-controlled, Multi-center Phase I / II Clinical Study to Assess the Safety and Efficacy of IDCT in Patients With Lumbar Degenerative Disc Disease
• Actual Study Start Date: May 23, 2019
• Estimated Primary Completion Date: February 1, 2021
• Estimated Study Completion Date: August 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: High Dose IDCT; Single intradiscal injection with High Dose IDCT (9M cells)	Biological: IDCT; Discogenic Cells + Sodium Hyaluronate Vehicle; Other Name: Injectable Disc Cell Therapy
Experimental: Low Dose IDCT; Single intradiscal injection with Low Dose IDCT (3M cells).	Biological: IDCT; Discogenic Cells + Sodium Hyaluronate Vehicle; Other Name: Injectable Disc Cell Therapy
Sham Comparator: Sham; Sham needle puncture (outside disc)	Procedure: Sham; Needle puncture under the muscular layer in front of the intervertebral disc

Outcome Measures

Primary Outcome Measures :

1. Safety as measured by number of Adverse Events [ Time Frame: 1 year ]
   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 AEs and SAEs observed from Day 1 to week 52
2. Efficacy (Pain): Visual Analogue Scale (VAS) [ Time Frame: 6 months ]
   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 :

1. Disability [ Time Frame: 1 year ]
   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
2. Efficacy (Pain): JOABPEQ [ Time Frame: 1 year ]
   Evaluate the effect of IDCT on pain as measured by JOABPEQ. The range of the score for each domain is from 0 to 100, with higher scores indicating a better condition.

Other Outcome Measures:

1. Radiographic Assessments [ Time Frame: 1 year ]
   To evaluate morphologic changes of treated intervertebral discs using MRI & X-Ray assessments.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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
• ODI score of 30 to 90.

Exclusion Criteria:

• 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.
• 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.

Contacts and Locations

Contacts

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

Locations

Japan

Chiba University Hospital; Not yet recruiting

Chuo-ku, Chiba Prefecture, Japan, 260-8670

Contact: Seiji Ohtori, M.D.,Ph.D.

Tokai University Hospital; Recruiting

Isehara, Kanagawa Prefecture, Japan, 259-1193

Contact: Daisuke Sakai, M.D, Ph.D. +81-463-93-1121 daisakai@is.icc.u-tokai.ac.jp

Mie University Hospital; Recruiting

Tsu city, Mie, Japan, 514-8507

Contact: Koji Akeda,, M.D.,Ph.D. +81-59-232-1111 k_akeda@clin.medic.mie-u.ac.jp

Nagoya university hospital; Recruiting

Showa-ku, Nagoya, Japan, 466-8550

Contact: Shiro Imagama, M.D, Ph.D +81-52-741-2111 imagama@med.nagoya-u.ac.jp

Osaka University Hospital; Recruiting

Suita, Osaka, Japan, 565-0871

Contact: Takashi Kaito, M.D, Ph.D +81-6-6879-5111 takashikaito@ort.med.osaka-u.ac.jp

University of Yamanashi Hospital; Recruiting

Chuo, Yamanashi Prefecture, Japan, 409-3898

Contact: Hirotaka Haro, M.D., Ph.D +81-55-273-1111 haro@yamanashi.ac.jp

Sponsors and Collaborators

DiscGenics, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: DiscGenics, Inc.
• ClinicalTrials.gov Identifier: NCT03955315
• Other Study ID Numbers: DGX-J01
• First Posted: May 20, 2019
• Last Update Posted: August 8, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases