Trial for Treating Painful Degenerative Disc Disease

Regenexx

Status: Enrolling

Conditions: Degenerative Disc Disease

Treatments: Biological: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP); Other: Sham procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT05287867

RGX2021-01

Details and patient eligibility

About

To evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.

Full description

This is a single-blind, randomized, placebo-controlled study using platelet-based treatment to the functional spinal unit .in a series of 2 treatments 4 weeks apart to treat painful lumbar degenerative disc disease. Randomization is 2:1, with 28 in the treatment group and 14 in the sham control group.

A pretreatment visit will occur at or before the time of enrollment; follow-up visits will occur at the clinical site at 3- and 12 months post injection. Target enrollment is 42 subjects. Patients in the control group can crossover to the treatment group after 3-month follow-up. Crossover patients then follow the treatment group follow-up timeline based on their second real treatment. Subjects will complete the study following the 1-year follow-up visit.

The primary objective of this study is to observe the improvement in subject-reported clinical outcomes from baseline to 3 months after 2nd treatment and between groups at 3 months, with continued evaluation of efficacy and durability up to 12 months. Questionnaires are completed at 1, 3, 6, and 12 months.

Enrollment: 42 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntary signature of the IRB approved Informed Consent,
• Skeletally mature Male or Female ages 25 to 65
• Maximum of 3 levels degenerative disc disease without significant spondylolisthesis in the area c/w the pain (grade 1 with less than or equal to 10% vertebral body)
• Chronic back and/or leg pain having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 6 months
• MRI and physical examination consistent with painful Degenerative Disc Disease
• Failure of epidural steroid injection, facet injection, medial branch block, radiofrequency ablation or physical therapy
• Instability as seen on MRI, flexion-extension x-ray, or physical deformity as seen on MRI c/w degenerative instability (facet hypertrophy, loss of disc height, spondylolisthesis, laterolisthesis, osteophytes)
• A lumbar surgery candidate (will need to specify which surgery, ie. fusion, decompression, etc)
• Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion criteria

• Evidence of more than moderate central canal or foraminal stenosis
• Smoker or cessation for less than 6 weeks
• Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor to chronic pain
• Prior epidural steroid injection within the past 8 weeks
• Degenerative scoliosis if cob angle over 10 degrees
• Undergone previous Regenexx lumbar procedure
• Standing intolerance (patient cannot stand longer than 30 minutes)
• Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
• Severe neurogenic inflammation of the cutaneous nerves
• Condition represents a worker's compensation case
• Currently involved in a health-related litigation procedure
• Is pregnant
• Bleeding disorders
• Currently taking anticoagulant or immunosuppressive medication
• Allergy or intolerance to study medication
• Use of chronic opioid
• Documented history of drug abuse within six months of treatment
• Central sensitization
• Hypermobile or EDS
• 19. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Platelet treatment

Experimental group

Description:

A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).

Treatment:

Biological: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)

Sham procedure

Sham Comparator group

Description:

A series of two sham procedures spaced 4 weeks apart.

Treatment:

Other: Sham procedure