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

OhioHealth

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Biological: BMAC injection; Biological: PRP injection; Device: Gel-One® hyaluronate injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02958267

OH1-16-00672

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

BMAC injection and PRP injection

Experimental group

Description:

Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.

Treatment:

Biological: BMAC injection

Biological: PRP injection

Gel-One® hyaluronate injection

Active Comparator group

Description:

Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).

Treatment:

Device: Gel-One® hyaluronate injection