Knee Osteoarthritis
Conditions
Keywords
knee, osteoarthritis, platelet rich plasma (PRP), bone marrow concentrate (BMC)
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.
Interventions
COMBINATION_PRODUCTPure PRP II
The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.
COMBINATION_PRODUCTPureBMC
The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.
Sponsors
EmCyte Corporation
BioSciences Research Associates, Inc
Andrews Research & Education Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomly assigned to either a PRP intervention group or the BMC intervention group. Knee pain and function outcomes of enrolled patients in the two groups will be compared to determine which treatment is more effective in treating knee osteoarthritis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet Rich Plasma (PRP) 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.
Pure PRP II: The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee. | 41 |
| Bone Marrow Concentrate (BMC) 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.
PureBMC: The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee. | 49 |
| Total | 90 |
Baseline characteristics
| Characteristic | Bone Marrow Concentrate (BMC) | Total | Platelet Rich Plasma (PRP) |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 11.3 | 54.1 years STANDARD_DEVIATION 11.9 | 52.2 years STANDARD_DEVIATION 12.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 49 participants | 90 participants | 41 participants |
| Sex: Female, Male Female | 21 Participants | 39 Participants | 18 Participants |
| Sex: Female, Male Male | 28 Participants | 51 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 49 |
| other Total, other adverse events | 0 / 41 | 0 / 49 |
| serious Total, serious adverse events | 0 / 41 | 2 / 49 |
Outcome results
Primary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Platelet Rich Plasma (PRP) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | Baseline | 32.1 score on a scale |
| Platelet Rich Plasma (PRP) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 1 month | 19.5 score on a scale |
| Platelet Rich Plasma (PRP) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 3 Months | 18.2 score on a scale |
| Platelet Rich Plasma (PRP) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 6 Months | 16.2 score on a scale |
| Platelet Rich Plasma (PRP) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 9 Months | 18.4 score on a scale |
| Platelet Rich Plasma (PRP) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 12 Months | 16.8 score on a scale |
| Bone Marrow Concentrate (BMC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 9 Months | 17.6 score on a scale |
| Bone Marrow Concentrate (BMC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | Baseline | 35.3 score on a scale |
| Bone Marrow Concentrate (BMC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 6 Months | 19.4 score on a scale |
| Bone Marrow Concentrate (BMC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 1 month | 19.8 score on a scale |
| Bone Marrow Concentrate (BMC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 12 Months | 19.4 score on a scale |
| Bone Marrow Concentrate (BMC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements | 3 Months | 15.2 score on a scale |
Secondary
Subjective International Knee Documentation Committee Subjective Score (IKDC)
Pain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Platelet Rich Plasma (PRP) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | Baseline | 47.4 score on a scale |
| Platelet Rich Plasma (PRP) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 1 Month | 58.4 score on a scale |
| Platelet Rich Plasma (PRP) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 3 Months | 61.6 score on a scale |
| Platelet Rich Plasma (PRP) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 6 Months | 65 score on a scale |
| Platelet Rich Plasma (PRP) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 9 Months | 63.1 score on a scale |
| Platelet Rich Plasma (PRP) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 12 Months | 63.7 score on a scale |
| Bone Marrow Concentrate (BMC) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 9 Months | 63.7 score on a scale |
| Bone Marrow Concentrate (BMC) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | Baseline | .909 score on a scale |
| Bone Marrow Concentrate (BMC) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 6 Months | 63.7 score on a scale |
| Bone Marrow Concentrate (BMC) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 1 Month | 58.5 score on a scale |
| Bone Marrow Concentrate (BMC) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 12 Months | 64.3 score on a scale |
| Bone Marrow Concentrate (BMC) | Subjective International Knee Documentation Committee Subjective Score (IKDC) | 3 Months | 63.6 score on a scale |