NCT02958267

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

Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: OhioHealth · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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BIOLOGICAL	PRP injection	60mL of venous blood will be withdrawn from either arm.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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2016-11-08
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

1 site across 1 country: United States