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

NCT02370823 | Terminated

• 1 other identifier: RSI2014-LAB01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean Change in Pain Scale from baseline to 6 weeks

  6 weeks

• Mean Change in IKDC Scores from baseline to 6 weeks

  6 weeks

• Incidence and time to resolution of post-operative complications and adverse events

  6 weeks

• Incidence and time to re-injection/re-operation

  6 weeks

Study Arms (1)

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

Interventions

Regenexx SD PROCEDURE

stem cell treatment

Also known as: Bone Marrow Concentrate

Knee OA Treated with Regenexx SD

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Knee injections of any type 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
• Symptomatic lumbar spine pathology (e.g. radicular pain)
• 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).
• Contraindications for MRI
• 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
• 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

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Synovial Fluid an QC bone marrow sample may be retained.

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christopher Centeno, MD

  Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 30, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)