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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lavage with Platelet Poor Plasma (PPP)

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee OA, lavage, Platelet Poor Plasma (PPP)

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centeno-Schultz Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lavage with Platelet Poor Plasma (PPP)

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean temporal biomarkers (pg/ml)

Secondary Outcome Measures

Mean Pain Scales

Mean International Knee Documentation Committee Subjective Knee Evaluation

Complications and adverse events

Mean temporal biomarkers (pg/ml)

Full Information

NCT ID

NCT03120988

First Posted

December 19, 2016

Last Updated

July 16, 2019

Sponsor

Regenexx, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03120988

Brief Title

Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage

Acronym

PPP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regenexx, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Knee OA, lavage, Platelet Poor Plasma (PPP)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Lavage with platelet poor plasma

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lavage with Platelet Poor Plasma (PPP)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Lavage with Platelet Poor Plasma (PPP)

Intervention Description

Lavage of 50cc PPP

Primary Outcome Measure Information:

Title

Mean temporal biomarkers (pg/ml)

Time Frame

4 weeks post treatment

Secondary Outcome Measure Information:

Title

Mean Pain Scales

Time Frame

2, 4 and 6 weeks post treatment

Title

Mean International Knee Documentation Committee Subjective Knee Evaluation

Time Frame

2, 4 and 6 weeks post treatment

Title

Complications and adverse events

Time Frame

2, 4 and 6 weeks post treatment

Title

Mean temporal biomarkers (pg/ml)

Time Frame

2 and 6 weeks post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Centeno, MD

Organizational Affiliation

Regenexx and Centeno-Schultz Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centeno-Schultz Clinic

City

Broomfield

State/Province

Colorado

ZIP/Postal Code

80021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24196662

Citation

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Results Reference

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PubMed Identifier

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Citation

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.

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PubMed Identifier

24124052

Citation

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.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage

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