NCT03120988

Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage

Assessing Catabolic Marker Levels in the Knee Synovial Fluid Microenvironment After Lavage With Platelet Poor Plasma (PPP)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Regenexx, LLC · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this study is to quantify the levels of catabolic markers in osteoarthritic (OA) knee synovial fluid microenvironment (ME) before lavage treatment with platelet poor plasma (PPP) and to determine whether the anti-catabolic capabilities of the PPP are sustainable or if the diseased synovial fluid returns to pre-lavage catabolic marker levels within the 6 week period of the study. This data will be used to determine if treatment of a diseased (OA) knee with PPP lavage would be a suitable therapy for knee OA patients either as a stand-alone treatment or to improve outcome by preparing a patient's knee microenvironment for further treatment with cellular therapies. Incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score will be considered while determining these direct and indirect associations upon completion of the PPP lavage treatment. Correlation of subject reported clinical outcomes for the PPP lavage treatment will be evaluated to determine whether the treatment provides beneficial clinical outcomes.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Lavage with Platelet Poor Plasma (PPP)	Lavage of 50cc PPP

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-06-30
• Completion: 2017-12-01
• First posted: 2017-04-19
• Last updated: 2019-07-17

Locations

1 site across 1 country: United States