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

NCT ID: NCT02370823

Last Updated: 2018-03-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-03-31

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Regenexx SD

Intervention Type: PROCEDURE

stem cell treatment

Interventions

Regenexx SD

stem cell treatment

Intervention Type: PROCEDURE

Other Intervention Names

Bone Marrow Concentrate

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regenexx, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Centeno, MD

Role: PRINCIPAL_INVESTIGATOR

Centeno-Schultz Clinic

Locations

Centeno-Schultz Clinic

Broomfield, Colorado, United States

Countries

United States

Other Identifiers

RSI2014-LAB01

Identifier Type: -

Identifier Source: org_study_id