Correlating the OA Knee Microenvironment to Outcomes After Regenexx-SD Treatment: A Multi-Site Study

NCT03898388 | Terminated

• 1 other identifier: RGX2018-LAB01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

Brief Summary

Multi-center study to include up to 600 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s. Synovial fluid drawn from patients' knee/s prior to receiving Regenexx-SD treatment will be correlated with their clinical outcomes after treatment.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  1\) Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to IKDC delta scores at 6 months.

  6 months after Regenexx-SD treatment

Secondary Outcomes (7)

• Correlation between components of synovial fluid to 12 month IKDC outcomes

  12 months

• Correlation between components of synovial fluid and 6 month pain score

  6 months

• Correlation between components of synovial fluid and 6 month Lower Extremity Function Scale (LEFS).

  6 months

• Correlation between components of synovial fluid and 6 month modified Single Assessment Numeric Evaluation (SANE)

  6 months

• Correlation between components of synovial fluid and 12 month pain scores

  12 months

Study Arms (1)

Knee Synovial Fluid collection before Regenexx-SD

EXPERIMENTAL

Measure components of knee synovial fluid 2-4 days before the Regenexx-SD treatment.

Procedure: Bone Marrow Concentrate treatment

Interventions

Bone Marrow Concentrate treatment PROCEDURE

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

Also known as: Regenexx®SD Treatment

Knee Synovial Fluid collection before Regenexx-SD

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 2) Unilateral or bilateral osteoarthritic 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 in one knee joint 5) 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.) 6) 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. 8) Knee surgery within 6 months prior to the study.
• \) Patient undergoing lavage with treatment
• \) 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) 11) Quinolone or statin-induced myopathy/tendinopathy 12) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh 13) Contraindications for MRI 14) Condition represents a worker's compensation case 15) Currently involved in a health-related litigation procedure 16) Is pregnant 17) Bleeding disorders 18) Currently taking anticoagulant or immunosuppressive medication 19) Allergy or intolerance to study medication 20) Use of chronic opioid 21) Documented history of drug abuse within six months of treatment 22) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (3)

Interventional Orthopedics of Atlanta

Atlanta, Georgia, 30305, United States

Location

Regenexx Des Moines

Des Moines, Iowa, 50321, United States

Location

Regenexx Las Vegas

Las Vegas, Nevada, 89074, United States

Location

Related Publications (4)

• Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z.

  PMID: 26385099 BACKGROUND

• Centeno C, Sheinkop M, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018 Dec 13;16(1):355. doi: 10.1186/s12967-018-1736-8.

  PMID: 30545387 BACKGROUND

• Themistocleous GS, Chloros GD, Kyrantzoulis IM, Georgokostas IA, Themistocleous MS, Papagelopoulos PJ, Savvidou OD. Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. Heliyon. 2018 Oct 18;4(10):e00871. doi: 10.1016/j.heliyon.2018.e00871. eCollection 2018 Oct.

  PMID: 30364761 BACKGROUND

• Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30.

  PMID: 27026621 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Centeno, MD

  Regenexx, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: March 21, 2019
• Primary Completion: October 30, 2020
• Study Completion: March 30, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)