Trial for Treating Painful Degenerative Disc Disease

NCT05287867 | Recruiting

• 1 other identifier: RGX2021-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Scale (NPS)

  Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain

  3-months after 2nd treatment

• Modified Single Assessment Numerical Evaluation (SANE) scores

  Difference in modified Single Assessment Numerical Evaluation score group differences; scores range from 0-100 where 0=no improvement and 100=100% improved

  3-months after 2nd treatment

Secondary Outcomes (7)

• Mean modified SANE scores

  1-month, 3-months, 6 months, 12 months

• Numeric Pain Scale (NPS)

  Baseline, 1-month, 3-months, 6 months, 12 months

• Functional Rating Index (FRI)

  Baseline, 1-month, 3-months, 6 months, 12 months

• Oswestry Disability Index (ODI)

  Baseline, 1-month, 3-months, 6 months, 12 months

• Incidence rate of adverse events

  1 month, 3 months, 6 months and 12 months

Study Arms (2)

Platelet treatment

EXPERIMENTAL

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

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

Sham procedure

SHAM COMPARATOR

A series of two sham procedures spaced 4 weeks apart.

Other: Sham procedure

Interventions

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

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.

Platelet treatment

Sham procedure OTHER

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.

Sham procedure

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (2)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

RECRUITING

Centeno-Schultz Clinic

Lone Tree, Colorado, 80124, United States

RECRUITING

Related Publications (8)

• Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):343-55.

  PMID: 20648203 BACKGROUND

• Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.

  PMID: 30560029 BACKGROUND

• Rodrigues SV, Acharya AB, Thakur SL. Platelet-rich plasma. A review. N Y State Dent J. 2012 Jan;78(1):26-30.

  PMID: 22474794 BACKGROUND

• Capelli C, Domenghini M, Borleri G, Bellavita P, Poma R, Carobbio A, Mico C, Rambaldi A, Golay J, Introna M. Human platelet lysate allows expansion and clinical grade production of mesenchymal stromal cells from small samples of bone marrow aspirates or marrow filter washouts. Bone Marrow Transplant. 2007 Oct;40(8):785-91. doi: 10.1038/sj.bmt.1705798. Epub 2007 Aug 6.

  PMID: 17680021 BACKGROUND

• Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371.

  PMID: 22023622 BACKGROUND

• Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.

  PMID: 29177632 BACKGROUND

• Williams C, Jerome M, Fausel C, Dodson E, Stemper I, Centeno C. Regenerative Injection Treatments Utilizing Platelet Products and Prolotherapy for Cervical Spine Pain: A Functional Spinal Unit Approach. Cureus. 2021 Oct 8;13(10):e18608. doi: 10.7759/cureus.18608. eCollection 2021 Oct.

  PMID: 34659923 BACKGROUND

• Phillips FM, Slosar PJ, Youssef JA, Andersson G, Papatheofanis F. Lumbar spine fusion for chronic low back pain due to degenerative disc disease: a systematic review. Spine (Phila Pa 1976). 2013 Apr 1;38(7):E409-22. doi: 10.1097/BRS.0b013e3182877f11.

  PMID: 23334400 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Christopher Centeno, MD

  Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehren Dodson, PhD

CONTACT

7202877199; edodson@regenexx.com

Neven Steinmetz, PhD

CONTACT

nsteinmetz@regenexx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 18, 2022
• Study Start: May 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)