Clinical trial

A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease

Name

RGX2021-01

Description

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.

Trial arms

Trial start

2022-05-06

Estimated PCD

2024-12-31

Trial end

2025-12-31

Status

Recruiting

Treatment

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

Approx 161-420cc autologous blood is drawn and processed into PPP, PRP, and PL, amount dependent on condition. Using sterile technique with patient sedated, US or x-ray is used to guide needles bilaterally into multifidus, specifically LM, TF, IAF. Once the lamina is reached the physician injects 2.5 cc of PPP into the multifidus muscle on one side and then repeat this on the opposite side for each level. The physician guides a needle into the supraneural transforaminal space to perform an epidural injection with 2cc of 4x PL and 1 cc of 0.5% ropivacaine. Next, a needle will then be guided into the facet joint to perform an intra-articular injection with 1cc of 14x PRP. Any tendon insertion areas will be injected using ultrasound guidance with platelet lysate dextrose. The supraspinous/interspinous, SI ligaments at the involved degenerative levels will be injected with 4x PL/12.5% dextrose/0.125% ropivacaine. If L5/S1 is involved, the iliolumbar ligaments will also be injected.

Arms:

Platelet treatment

Sham procedure

Approximately 161-420 cc of autologous blood is drawn to maintain patient blinding. While lying prone, the patient's back will be exposed and prepped sterilely. Provider puts patient in conscious sedation and several needles are placed into the low back. The provider inserts needle into the facet joint and then removes. Then inserts the needle midline to ligament and removes (1 needle per level) mimicking normal needle placement, but not injecting anything.

Arms:

Sham procedure

Size

Primary endpoint

Numeric Pain Scale (NPS)

3-months after 2nd treatment

Modified Single Assessment Numerical Evaluation (SANE) scores

3-months after 2nd treatment

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Single-blind', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}

Updated at

2023-09-26

1 organization

Organization

Regenexx