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

NCT ID: NCT02958267

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-08-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BMAC injection and PRP injection

Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.

Group Type: EXPERIMENTAL

BMAC injection

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

60mL of venous blood will be withdrawn from either arm.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.

Gel-One® hyaluronate injection

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

Group Type: ACTIVE_COMPARATOR

Gel-One® hyaluronate injection

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Joseph Ruane

Principal Investigator - Medical Director, McConnell Heart Health Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph J Ruane, DO

Role: PRINCIPAL_INVESTIGATOR

Medical Director, McConnell Heart Health Center

Locations

McConnell Spine, Sport, and Joint Physicians

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34434003 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OH1-16-00672

Identifier Type: -

Identifier Source: org_study_id