Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage

NCT03120988 | Completed Phase 1

• 1 other identifier: RSI2015-LAB03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how the components of osteoarthritic knee joint fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally, the study participants will complete outcome questionnaire surveys before and after the treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks after lavage). This data will help determine if the treatment of an osteoarthritic knee joint with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by preparing a patient's knee for further regenerative therapies.

Conditions

Knee Osteoarthritis

Keywords

Knee OA; lavage; Platelet Poor Plasma (PPP)

Outcome Measures

Primary Outcomes (1)

• Mean temporal biomarkers (pg/ml)

  4 weeks post treatment

Secondary Outcomes (4)

• Mean Pain Scales

  2, 4 and 6 weeks post treatment

• Mean International Knee Documentation Committee Subjective Knee Evaluation

  2, 4 and 6 weeks post treatment

• Complications and adverse events

  2, 4 and 6 weeks post treatment

• Mean temporal biomarkers (pg/ml)

  2 and 6 weeks post treatment

Study Arms (1)

Lavage with Platelet Poor Plasma (PPP)

EXPERIMENTAL

Lavage using 50 cc of PPP in the knee joint. Using visual guidance, the PPP lavage will be conducted, introducing a solution of platelet poor plasma into the knee joint with subsequent removal of the fluid, in effect "washing out" the joint space.

Biological: Lavage with Platelet Poor Plasma (PPP)

Interventions

Lavage with Platelet Poor Plasma (PPP) BIOLOGICAL

Lavage of 50cc PPP

Lavage with Platelet Poor Plasma (PPP)

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Voluntary signature of the institutional review board approved Informed Consent
• \) Male or female ages 35-85
• \) Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
• \) Physical examination consistent with osteoarthritis as observed on imaging
• \) Unilateral or bilateral Kellgren-Lawrence grade 3 or greater knee osteoarthritis (moderate to severe OA) and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc…)
• \) Mild effusion upon ultrasound evaluation.
• \) Is independent, ambulatory, and can comply with all postoperative evaluations and visits

You may not qualify if:

• \) Knee injections of any type within 3 months prior to the study.
• \) Knee surgery within 6 months prior to the study.
• \) Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
• \) Quinolone or Statin induced myopathy/tendinopathy
• \) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
• \) Contraindications for MRI
• \) 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
• )Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Related Publications (9)

• Centers for Disease Control and Prevention (CDC). Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):869-73.

  PMID: 24196662 BACKGROUND

• Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

  PMID: 18163497 BACKGROUND

• Waimann CA, Fernandez-Mazarambroz RJ, Cantor SB, Lopez-Olivo MA, Zhang H, Landon GC, Siff SJ, Suarez-Almazor ME. Cost-effectiveness of total knee replacement: a prospective cohort study. Arthritis Care Res (Hoboken). 2014 Apr;66(4):592-9. doi: 10.1002/acr.22186.

  PMID: 24124052 BACKGROUND

• Katz JN, Brophy RH, Chaisson CE, de Chaves L, Cole BJ, Dahm DL, Donnell-Fink LA, Guermazi A, Haas AK, Jones MH, Levy BA, Mandl LA, Martin SD, Marx RG, Miniaci A, Matava MJ, Palmisano J, Reinke EK, Richardson BE, Rome BN, Safran-Norton CE, Skoniecki DJ, Solomon DH, Smith MV, Spindler KP, Stuart MJ, Wright J, Wright RW, Losina E. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18.

  PMID: 23506518 BACKGROUND

• Getgood A, Collins B, Slynarski K, Kurowska E, Parker D, Engebretsen L, MacDonald PB, Litchfield R. Short-term safety and efficacy of a novel high tibial osteotomy system: a case controlled study. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):260-9. doi: 10.1007/s00167-011-1709-4. Epub 2011 Oct 18.

  PMID: 22005964 BACKGROUND

• Goldring MB, Otero M. Inflammation in osteoarthritis. Curr Opin Rheumatol. 2011 Sep;23(5):471-8. doi: 10.1097/BOR.0b013e328349c2b1.

  PMID: 21788902 BACKGROUND

• Wang S, Wei X, Zhou J, Zhang J, Li K, Chen Q, Terek R, Fleming BC, Goldring MB, Ehrlich MG, Zhang G, Wei L. Identification of alpha2-macroglobulin as a master inhibitor of cartilage-degrading factors that attenuates the progression of posttraumatic osteoarthritis. Arthritis Rheumatol. 2014 Jul;66(7):1843-53. doi: 10.1002/art.38576.

  PMID: 24578232 BACKGROUND

• Rehman AA, Ahsan H, Khan FH. alpha-2-Macroglobulin: a physiological guardian. J Cell Physiol. 2013 Aug;228(8):1665-75. doi: 10.1002/jcp.24266.

  PMID: 23086799 BACKGROUND

• Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documentation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct;34(10):1567-73. doi: 10.1177/0363546506288855. Epub 2006 Jul 26.

  PMID: 16870824 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Christopher Centeno, MD

  Regenexx and Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Lavage with platelet poor plasma

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: April 19, 2017
• Study Start: July 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: December 1, 2017
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)