Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage (PPP)

July 16, 2019 updated by: Regenexx, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Broomfield, Colorado, United States, 80021
        • Centeno-Schultz Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) Voluntary signature of the institutional review board approved Informed Consent
  • 2) Male or female ages 35-85
  • 3) Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
  • 4) Physical examination consistent with osteoarthritis as observed on imaging
  • 5) 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…)
  • 6) Mild effusion upon ultrasound evaluation.
  • 7) Is independent, ambulatory, and can comply with all postoperative evaluations and visits

Exclusion Criteria:

  • 1) Knee injections of any type within 3 months prior to the study.
  • 2) Knee surgery within 6 months prior to the study.
  • 3) 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)
  • 4) Quinolone or Statin induced myopathy/tendinopathy
  • 5) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
  • 6) Contraindications for MRI
  • 7) Condition represents a worker's compensation case
  • 8) Currently involved in a health-related litigation procedure
  • 9) Is pregnant
  • 10) Bleeding disorders
  • 11) Currently taking anticoagulant or immunosuppressive medication
  • 12)Allergy or intolerance to study medication
  • 13)Use of chronic opioid
  • 14)Documented history of drug abuse within six months of treatment
  • 15)Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lavage with Platelet Poor Plasma (PPP)
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)
Lavage of 50cc PPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean temporal biomarkers (pg/ml)
Time Frame: 4 weeks post treatment
4 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Pain Scales
Time Frame: 2, 4 and 6 weeks post treatment
2, 4 and 6 weeks post treatment
Mean International Knee Documentation Committee Subjective Knee Evaluation
Time Frame: 2, 4 and 6 weeks post treatment
2, 4 and 6 weeks post treatment
Complications and adverse events
Time Frame: 2, 4 and 6 weeks post treatment
2, 4 and 6 weeks post treatment
Mean temporal biomarkers (pg/ml)
Time Frame: 2 and 6 weeks post treatment
2 and 6 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regenexx, LLC

Investigators

  • Principal Investigator: Christopher Centeno, MD, Regenexx and Centeno-Schultz Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

April 14, 2017

First Posted (ACTUAL)

April 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSI2015-LAB03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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