CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

NCT ID: NCT03113786

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-02
• Study Completion Date: 2020-04-21

Brief Summary

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.

Conditions

Protruded Disk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

CLARIX™100

Intervention Type: OTHER

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).

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.

Group Type: ACTIVE_COMPARATOR

CLARIX CORD 1K

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amniox Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scheffer Tseng, MD, PhD

Role: STUDY_CHAIR

BioTissue Holdings, Inc

Locations

Rothman Institute

Bensalem, Pennsylvania, United States

Countries

United States

Other Identifiers

CR-1001

Identifier Type: -

Identifier Source: org_study_id