Overview

This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatment regenexx sd - same day bone marrow concentrate injection
Sponsor Regenerative Sciences, LLC
Start date February 2015
End date August 2015
Trial size 20 participants
Trial identifier NCT02370823, RSI2014-LAB01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
regenexx sd - same day bone marrow concentrate injection Bone Marrow Concentrate
Regenexx®SD (Same Day) is a bone marrow based stem cell procedure. Spinning down bone marrow in a bedside machine produces a set amount of stem cells to be injected.

Primary Outcomes

Measure
Median change in protein concentration or percentage of cellular subpopulations
time frame: 6 weeks compared to baseline

Secondary Outcomes

Measure
Mean Change in Pain Scale from baseline to 6 weeks
time frame: 6 weeks
Mean Change in IKDC Scores from baseline to 6 weeks
time frame: 6 weeks
Incidence and time to resolution of post-operative complications and adverse events
time frame: 6 weeks
Incidence and time to re-injection/re-operation
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 35 years up to 85 years old.

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

Additional Information

Official title A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
Principal investigator Christopher Centeno, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Regenerative Sciences, LLC.