Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment

NCT02848027 | Completed Phase 3

• 1 other identifier: RSI2015-LAB02
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single-center, lab blinded to include up to 400 subjects with knee osteoarthritis. Collection of synovial fluid from diseased knee before and after Regenexx®SD treatment will serve as the experimental condition, i.e. the osteoarthritic knee.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure.

  Synovial fluid components include cytokine, matrix metalloproteinase levels, and catabolic cartilage breakdown products. These components of synovial fluid will be correlated to the following patient-reported outcomes 6 months after procedure: the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form.

  6 months after Regenexx-SD procedure

Secondary Outcomes (1)

• Comparison of synovial fluid contents

  fluid taken ~2-4 days before procedure and ~2-4 days after procedure

Study Arms (1)

Regenexx-SD procedure

EXPERIMENTAL

Measure components of knee synovial fluid collected 2-4 days before and after Regenexx SD procedure

Biological: Regenexx SD® procedure

Interventions

Regenexx SD® procedure BIOLOGICAL

Correlate patient outcomes 6 months after receiving the Regenexx SD procedure with measurements of synovial fluid collected before and after procedure.

Regenexx-SD procedure

Eligibility Criteria

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

You may qualify if:

• Voluntary signature of the IRB approved Informed Consent
• Unilateral or bilateral osteoarthritic male or female ages 35-85
• Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
• Physical examination consistent with osteoarthritis in one knee joint
• Kellgren-Lawrence grade 2 or greater knee osteoarthritis 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…)
• Is independent, ambulatory, and can comply with all post-operative evaluations and visits

You may not qualify if:

• Knee injections of any type within 3 months prior to the study.
• Knee surgery 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
• Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
• Contraindications for MRI
• 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
• Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Sponsors & Collaborators

• Regenexx, LLC: lead

Related Publications (6)

• Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4.

  PMID: 16956842 BACKGROUND

• Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371.

  PMID: 22023622 BACKGROUND

• Centeno CJ, Schultz JR, Cheever M, Robinson B, Freeman M, Marasco W. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2010 Mar;5(1):81-93. doi: 10.2174/157488810790442796.

  PMID: 19951252 BACKGROUND

• Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14.

  PMID: 20392971 BACKGROUND

• Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.

  PMID: 20603892 BACKGROUND

• Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documentation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct;34(10):1567-73. doi: 10.1177/0363546506288855. Epub 2006 Jul 26.

  PMID: 16870824 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Neven Steinmetz, Ph.D.

  Regenexx, LLC

  STUDY DIRECTOR

• Christopher J Centeno, M.D.

  Regenexx, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: July 28, 2016
• Study Start: September 8, 2015
• Primary Completion: June 30, 2020
• Study Completion: August 19, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share