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

NCT02958267 | Completed Phase 2 Results

• 1 other identifier: OH1-16-00672
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

knee osteoarthritis; regenerative medicine; orthobiologics; cellular therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Numeric Pain Rating Scale

  Change from baseline to 3, 6, and 12 months post-treatment

• Patient Reported Outcome Measurement Information System Global Health Scores

  Change from baseline to 3, 6, and 12 months post-treatment

Study Arms (2)

BMAC injection and PRP injection

EXPERIMENTAL

Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.

Biological: BMAC injection; Biological: PRP injection

Gel-One® hyaluronate injection

ACTIVE COMPARATOR

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

Device: Gel-One® hyaluronate injection

Interventions

BMAC injection 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.

BMAC injection and PRP injection

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60mL of venous blood will be withdrawn from either arm.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

BMAC injection and PRP injection

Gel-One® hyaluronate injection 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.

Gel-One® hyaluronate injection

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 40 to 70 years old
• Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings
• Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic
• Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months
• Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week
• Previous trial of 6 weeks minimum of conservative therapy including physical therapy, weight loss, anti-inflammatory medication, or injection therapy

You may not qualify if:

• Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale
• 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
• 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)
• Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)
• Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle
• Clinically apparent tense effusion or other acute inflammation of the target knee at the time of presentation to the clinic
• 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
• 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
• Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of the target knee
• Significant alignment deformity such as varus/valgus of the target knee in the judgment of the investigator
• Currently pregnant, nursing, or planning to become pregnant during the trial period
• 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
• Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)
• 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
• Current cigarette smoker

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

McConnell Spine, Sport, and Joint Physicians

Columbus, Ohio, 43214, United States

Location

Related Publications (1)

• 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.

  PMID: 34434003 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Joseph J Ruane, DO
• Organization: OhioHealth

joseph.ruane@ohiohealth.com

614-566-3810

Study Officials

• Joseph J Ruane, DO

  Medical Director, McConnell Heart Health Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Medical Director, McConnell Heart Health Center

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 8, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-09

Locations

US (1)