Clinical trial NCT02958267: Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee
Official title: Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
regenerative medicine
orthobiologics
cellular therapy
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Change from baseline to 3, 6, and 12 months post-treatment
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Change from baseline to 3, 6, and 12 months post-treatment
measure: Patient Reported Outcome Measurement Information System Global Health Scores
timeFrame: Change from baseline to 3, 6, and 12 months post-treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: McConnell Spine, Sport, and Joint Physicians
state: Ohio
Study officials:
affiliation: Medical Director, McConnell Heart Health Center
name: Joseph J Ruane, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruane JJ, Ross A, Zigmont V, McClure D, Gascon G. A Single-Blinded Randomized Controlled Trial of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee with Active Control. J Stem Cells Regen Med. 2021 Jan 2;17(1):3-17. doi: 10.46582/jsrm.1701002. eCollection 2021.