Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level, Symptomatic Lumbar Intervertebral Disc Degeneration

NCT02379689 | Unknown

• 1 other identifier: Parker 1001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, the investigators hope to find a safe and effective way to treat degenerative disc disease.

Conditions

Degenerative Disc Disease; Pain

Keywords

psychosocial state

Outcome Measures

Primary Outcomes (3)

• • To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract (IPE) on lower back pain (VAS).

  52 weeks

• • To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on disability (ODI).

  52 weeks

• • To evaluate the effect on change from baseline compared to Tissue Suspension Solution of intradiscal placental extract on quality of life (EQ-5D).

  52 weeks

Secondary Outcomes (1)

• • Composite outcome measure: Change from baseline and compared to Tissue Suspension Solution in qualitative assessments

  52 weeks

Study Arms (2)

injectable placental tissue extract called BioDGenesis

ACTIVE COMPARATOR

This study will compare injectable placental tissue extract called BioDGenesis (Active Product)

Drug: Injectable placental tissue extract called BioDGenesis (Active Product)

Placebo

PLACEBO COMPARATOR

injectable Tissue Suspension Solution (TSS) (Placebo). The Active Product is supplied by BioD, LLC (BioD).

Drug: Placebo

Interventions

Injectable placental tissue extract called BioDGenesis (Active Product) DRUG

injectable placental tissue extract called BioDGenesis

Placebo DRUG

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must be ≥18 and ≤75 years of age, skeletally mature, and have a BMI ≥18 kg/m2 and ≤30 kg/m2 at Screening.
• The subject must have been experiencing low back pain for at least 6 months prior to Screening.
• The subject must have had low back pain that is unresponsive to at least 3 months of conservative care (non operative treatment), which may include bed rest, anti inflammatory or analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise programs.
• The subject must have pretreatment (Baseline) low back pain of 30 to 90 mm on the visual analog scale (VAS) at Screening and Baseline.
• The subject must have pretreatment (Baseline) Oswestry Disability Index Questionnaire (ODI) score of 30 to 70 points at Screening and Baseline.
• The subject's target disc must meet the following objective criteria (corresponding to Pfirrman Grade 2 and 3):
• The subject must be willing to voluntarily sign the informed consent form and agree to the release of medical information for purposes of this study (i.e., HIPAA authorization) at Screening.
• The subject must be physically and mentally able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol.

You may not qualify if:

• The subject has radiculopathy resulting from nerve compression at Screening or Baseline.
• The subject has unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low back pain as measured on a VAS at Screening or Baseline.
• The subject has cauda equina syndrome at Screening or Baseline (Day 1).
• The subject has greater than 50% loss of disc height when compared to the adjacent superior disc.
• The subject has a significant disc herniation or free fragment of disc material on MRI.
• The subject has current infection at the planned procedure site, active systemic infection, or current or prior history of lumbar spinal infection (i.e., discitis, septic arthritis, epidural abscess) at Baseline.
• The subject has had previous lumbar spine surgery.
• The subject has had previous disc treatment procedures or intradiscal injections. Discography may have been performed, but the procedure must have been done at least 2 weeks or more prior to the injection of study medication.
• The subject has undergone lumbar epidural or transforaminal injections with corticosteroids within the last 3 months.
• The subject has evidence of prior lumbar vertebral body fracture or trauma.
• The subject has evidence of dynamic instability on lumbar flexion extension.
• The subject has Grade 2 or higher spondylolisthesis or spondylolysis at the target disc at Screening.
• The subject has findings of a significant underlying neurological condition (motor strength \<4; sensory assessment abnormal; or reflexes absent or hyperactive with clonus).
• The subject has an active malignancy or tumor.
• The subject has had significant systemic disease, such as unstable angina, autoimmune disease, rheumatoid arthritis, diabetes mellitus, or muscular dystrophy.

Sponsors & Collaborators

• Semmes-Murphey Foundation: lead

Study Sites (1)

Western Institutional Review Board® (WIRB®)

Puyallup, Washington, Washington, 98374-2115, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Autry Parker, M.D.

CONTACT

(901) 259-5324

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 5, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (1)