CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

Efficacy of Amniotic Tissue (CLARIX 100 & CLARIX CORD 1K) in Pain Reduction and Improvement of Function in Low Back & Leg Pain in Discectomy Patients

The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back & leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized study model over a 5 year post-operative period.

Study Overview

• Status: Completed
• Conditions: Protruded Disk
• Intervention / Treatment: Other: CLARIX™100; Other: CLARIX CORD 1K

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between 18 and 90 years of age
• Patient is able to understand the aims and objectives of the trial and the trial procedures
• Patient is willing to give written informed consent to the trial
• Patient is able to follow up with regularly scheduled visits with and phone calls from Dr. Anderson and his research staff
• Diagnosed with lumbar protruding disc
• Suffer from radiating leg pain and low back pain that has failed a minimum of 6 months of conservative (non-operative) treatment options

Exclusion Criteria:

• Participation in clinical trial involving therapy for back pain within 30 days of screening
• Prior back surgery at the same level
• Inability to walk independently (adaptive devices such as walkers or canes are allowed)
• Relation (whether direct or indirect) to, student of, employee of, colleague of, indebted to the primary investigator, host institution or sponsoring company
• Receipt of corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within 1 month prior to visit
• Pregnancy or planning to become pregnant during study period
• Body Mass Index >50
• Patients with chronic diseases such as Crohn's disease, severe renal failure (serum creatinine 2.5 mg/dL or subject on hemodialysis), severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal, life expectancy of less than one year, uncompensated or uncontrolled right sided heart failure with associated edema
• Severe anemia, hemoglobin <8.5 mg/dL
• Active, local or systemic malignancy such as lung cancer or leukemia
• Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 100 mmHg)
• Severe hypoxia, with chronic oxygen or ventilation therapy
• History of collagen vascular disease or sickle cell anemia
• Active rheumatoid arthritis
• Systemic antibiotic therapy for any indication within 10 days of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions
Active Comparator: CLARIX™100; Subjects randomized to the CLARIX™100 arm will undergo a traditional lumbar discectomy, after which CLARIX™100 will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure.	Other: CLARIX™100; CLARIX™100 is Amniox's processed and cryopreserved human amniotic membrane tissue retrieved from donated placental tissue after elective Cesarean Section delivery. Amniox's Amniotic Membrane is designated by the FDA as a tissue product under PHS 361 HCT/P (human cells, tissues and cellular and tissue-based products).
Active Comparator: CLARIX CORD 1K; Subjects randomized to the CLARIX CORD 1K arm will undergo a traditional lumbar discectomy, after which CLARIX CORD 1K will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure.	Other: CLARIX CORD 1K; CLARIX CORD 1K is made from cryopreserved human umbilical cord, utilizing the patented CRYOTEK™ process. CLARIX CORD 1K is considered a Human Cells, Tissues & Cellular and Tissue-based product (HCT/P) by U.S. FDA standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in low back & leg pain	To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the Oswestry Disability Index scales for both back & leg pain	5 years
Difference in low back & leg pain	To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the SF-12 scale for both back & leg pain	5 years
Difference in low back & leg pain	To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the VAS for both back & leg pain	5 years

Collaborators and Investigators

• Sponsor: Amniox Medical, Inc.
• Investigators: Study Chair: Scheffer Tseng, MD, PhD, Tissue Tech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2011
• Primary Completion (Actual): April 21, 2020
• Study Completion (Actual): April 21, 2020

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Discectomy; Lumbar discectomy; Protruding disc
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: CR-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No