A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment

The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Regenexx SD

Detailed Description

The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx SD treatment (day 0).

Secondary objective is an evaluation of possible direct and/or indirect associations between the measured levels of proteins and/or cellular components of the synovial fluid in the osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary objective will include MRI evidence of cartilage repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will have unilateral knee OA as evidenced with physical examination and MRI. Subjects will be recruited from the physician practice and will be males and females age 35-85.

Description

Inclusion Criteria:

1. Voluntary signature of the IRB approved Informed Consent
2. Unilateral osteoarthritic male or female ages 35-85
3. Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint
4. Physical examination consistent with osteoarthritis in one knee joint
5. Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension)
6. Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of the affected knee showing osteoarthritis
7. Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.)
8. Normal range of motion of the unaffected knee
9. No sign of pain, swelling, and/or functional disability of the unaffected knee
10. No history of acute injury in the unaffected knee
11. Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria:

1. Knee injections of any type within 6 months prior to the study.
2. 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)
3. Quinolone or Statin induced myopathy/tendinopathy
4. Symptomatic lumbar spine pathology (e.g. radicular pain)
5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam).
6. Contraindications for MRI
7. Tested positive or has been treated for a malignancy in the past five years or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
8. Condition represents a worker's compensation case
9. Currently involved in a health-related litigation procedure
10. Is pregnant
11. Bleeding disorders
12. Currently taking anticoagulant or immunosuppressive medication
13. Allergy or intolerance to study medication
14. Use of chronic opioid
15. Documented history of drug abuse within six months of treatment

18) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Knee OA Treated with Regenexx SD; 20 subjects with unilateral knee osteoarthritis. Collection of synovial fluid from both knees will serve as the experimental condition, i.e. the osteoarthritic knee, and the matched control, i.e. the knee not demonstrating signs of osteoarthritis. Alterations in the concentration of the synovial fluid proteins and cellular components will be evaluated up to 6 weeks post-Regenexx® SD - Same Day Bone Marrow Concentrate Injection treatment.

Procedure: Regenexx SD; stem cell treatment; Other Names: Bone Marrow Concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median change in protein concentration or percentage of cellular subpopulations	A comparison of the patient temporal median change in protein concentration or percentage of cellular subpopulations from pre-injection to 6 weeks post- Regenexx SD treatment.	6 weeks compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Pain Scale from baseline to 6 weeks	Mean Numeric Pain Scale	6 weeks
Mean Change in IKDC Scores from baseline to 6 weeks	Mean Patient Reported Pain and Function Scale	6 weeks
Incidence and time to resolution of post-operative complications and adverse events	Incidence and time to resolution of post-operative complications and adverse events	6 weeks
Incidence and time to re-injection/re-operation	Incidence and time to re-injection/re-operation	6 weeks

Collaborators and Investigators

• Sponsor: Regenexx, LLC
• Investigators: Principal Investigator: Christopher Centeno, MD, Centeno-Schultz Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RSI2014-LAB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No