Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis

Phase 4

Completed

Conditions: Knee Osteoarthritis

Interventions: Combination Product: Pure PRP II
Combination Product: PureBMC

Registration Number: NCT03289416

Lead Sponsor: Andrews Research & Education Foundation

Brief Summary: This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.

Detailed Description: While PRP shows promise in helping restore function to these patients, there are still concerns with PRP's long term outcomes. Another option that has become more popular for physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA), which use's undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. These cells have the ability to replicate into a multiple different tissue types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts.

Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. However, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of BMA for osteoarthritis treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

Inclusion Criteria

Male or female age 18-80 years
Knee osteoarthritis
Subjects must present with pain or swelling to target knee for at least 4 months
Kellgren-Lawrence score between 1 and 3 upon x-ray evaluation
Must be willing and able to provide informed consent
Willing and able to return for scheduled follow-up visits

Exclusion Criteria

Major mechanical axis deviation of more than 50% into either compartment (varus or valgus )
Have had a corticosteroid injection within 3 months or a hyaluronic acid injection within 6 months
History of the following medical conditions:
diabetes
autoimmune disorders
disorders requiring immunosuppression
rheumatoid arthritis
hemophilic arthropathy
infectious arthritis
Charcot's knee
Paget's disease of the femur or tibia
Cancer
Ongoing infectious disease
Significant cardiovascular, renal or hepatic disease

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma (PRP)	Pure PRP II	Blood will be drawn from the patient using the Pure PRP II system into a syringe with anticoagulant (sodium citrate). 1 mL of blood will be separated and sent to a lab for analysis. Remaining blood will be separated into a single concentrating device and centrifuged to separate red blood cells from plasma and platelets. The plasma and platelets will be separated off with a syringe and re-centrifuged to separate the platelets from the plasma. 1 mL will be separated and sent to a lab for analysis leaving 6 mL for injection. Both the 1 mL of blood and the 1 mL of PRP will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F. Physician will then inject the PRP into the affected knee joint.
Bone Marrow Concentrate (BMC)	PureBMC	Bone marrow will be harvested from the posterior iliac crest using the PureBMC system. 50 mL of bone marrow will be drawn into one syringe containing 10 mL of sodium citrate. Marrow will be filtered and centrifuged for separation of the bone marrow concentrate. Plasma and cell concentrate will be separated off with two syringes and re-centrifuged to separate the cell concentrate from the plasma. After plasma is drawn off, BMC will be drawn into a syringe for injection into affected knee. BMC production procedure results in 7 mL of product and 1 mL will be separated and sent to a lab for analysis. Both 1 mL of BMA and 1 mL of BMC will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F.

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements	Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months	Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain

Secondary Outcome Measures

Name	Time	Method
Subjective International Knee Documentation Committee Subjective Score (IKDC)	Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months	Pain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest