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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02370823
• Other study ID #: RSI2014-LAB01
• Status: Terminated
• First received: February 10, 2015
• Last updated: March 28, 2018
• Start date: February 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Regenerative Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Regenexx SD
stem cell treatment

Locations

Country	Name	City	State
United States	Centeno-Schultz Clinic	Broomfield	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Regenerative Sciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Change in Pain Scale from baseline to 6 weeks	Mean Numeric Pain Scale	6 weeks
Secondary	Mean Change in IKDC Scores from baseline to 6 weeks	Mean Patient Reported Pain and Function Scale	6 weeks
Secondary	Incidence and time to resolution of post-operative complications and adverse events	Incidence and time to resolution of post-operative complications and adverse events	6 weeks
Secondary	Incidence and time to re-injection/re-operation	Incidence and time to re-injection/re-operation	6 weeks