Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee

Knee Osteoarthritis Clinical Trial

Official title:

Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958267
• Other study ID #: OH1-16-00672
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2019
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Specifically, the clinical response will be compared to baseline and a control group treated with a Gel-One® hyaluronate injection to the target knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male and female patients 40 to 70 years old

2. Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings

3. Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic

4. Symptomatic evidence of tibiofemoral osteoarthritis for =6 months

5. Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week

6. Previous trial of 6 weeks minimum of conservative therapy including physical therapy, weight loss, anti-inflammatory medication, or injection therapy

Exclusion Criteria:

1. Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale

2. History of intraarticular viscosupplementation or steroid injection in the target knee in the past 6 months at the time of the baseline visit or intraarticular injection planned during the trial

3. History of arthroscopic surgery in the target knee in the past 12 months at the time of presentation to the clinic or planned surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)

4. Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)

5. Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle

6. Clinically apparent tense effusion or other acute inflammation of the target knee at the time of presentation to the clinic

7. Active infection of either lower extremity such as cellulitis or any skin disease or infection in the area where BMAC is aspirated, blood is drawn, or an injection is given

8. History of diagnosis of any of the following: 1) septic osteoarthritis of any joint, 2) inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnoses

9. Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of the target knee

10. Significant alignment deformity such as varus/valgus of the target knee in the judgment of the investigator

11. Currently pregnant, nursing, or planning to become pregnant during the trial period

12. Previous or known allergic reaction or hypersensitivity to heparin; sodium citrate; hyaluronan products or specifically Gel-One®; cinnamon; bird products such as feathers, eggs, or poultry; avian proteins

13. Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)

14. Unable to be prescribed stable dose of NSAIDs and/or tramadol based on medical history as ad lib use of over-the-counter analgesics will be allowed in both groups after treatment

15. Current cigarette smoker

16. Unable to give informed consent

17. Non-English speaking

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• BMAC injection
60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
• PRP injection
60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.

Device:
• Gel-One® hyaluronate injection
Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.

Locations

Country	Name	City	State
United States	McConnell Spine, Sport, and Joint Physicians	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score	Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.	Change from baseline to 3, 6, and 12 months post-treatment
Secondary	Numeric Pain Rating Scale	Scale from 0-10 with 0 representing "no pain" and 10 representing "worst imaginable pain"	Change from baseline to 3, 6, and 12 months post-treatment
Secondary	Patient Reported Outcome Measurement Information System Global Health Scores	The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value.	Change from baseline to 3, 6, and 12 months post-treatment