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

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Knee Osteoarthritis
Interventions
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.

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60mL of venous blood will be withdrawn from either arm.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

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.

Trial Locations (1)

43214

McConnell Spine, Sport, and Joint Physicians, Columbus

Sponsors

Lead Sponsor

All Listed Sponsors
lead

OhioHealth

OTHER

NCT02958267 - Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee | Biotech Hunter | Biotech Hunter