Trial Outcomes & Findings for Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis (NCT NCT03289416)
NCT ID: NCT03289416
Last Updated: 2025-04-20
Results Overview
Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Results posted on
2025-04-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
|
41
|
49
|
|
Overall Study
COMPLETED
|
41
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Platelet Rich Plasma (PRP)
n=41 Participants
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.
|
Bone Marrow Concentrate (BMC)
n=49 Participants
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.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 12.4 • n=41 Participants
|
55.8 years
STANDARD_DEVIATION 11.3 • n=49 Participants
|
54.1 years
STANDARD_DEVIATION 11.9 • n=90 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=41 Participants
|
21 Participants
n=49 Participants
|
39 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=41 Participants
|
28 Participants
n=49 Participants
|
51 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
41 participants
n=41 Participants
|
49 participants
n=49 Participants
|
90 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 monthsPain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain
Outcome measures
| Measure |
Platelet Rich Plasma (PRP)
n=41 Participants
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.
|
Bone Marrow Concentrate (BMC)
n=49 Participants
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.
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
Baseline
|
32.1 score on a scale
Interval 26.4 to 37.9
|
35.3 score on a scale
Interval 29.9 to 40.6
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
1 month
|
19.5 score on a scale
Interval 14.6 to 24.4
|
19.8 score on a scale
Interval 15.2 to 24.3
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
3 Months
|
18.2 score on a scale
Interval 13.7 to 22.8
|
15.2 score on a scale
Interval 11.0 to 19.4
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
6 Months
|
16.2 score on a scale
Interval 11.0 to 21.5
|
19.4 score on a scale
Interval 14.5 to 24.3
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
9 Months
|
18.4 score on a scale
Interval 13.1 to 23.7
|
17.6 score on a scale
Interval 12.7 to 22.6
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
12 Months
|
16.8 score on a scale
Interval 11.5 to 22.1
|
19.4 score on a scale
Interval 14.5 to 24.3
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 monthsPain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest
Outcome measures
| Measure |
Platelet Rich Plasma (PRP)
n=41 Participants
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.
|
Bone Marrow Concentrate (BMC)
n=49 Participants
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.
|
|---|---|---|
|
Subjective International Knee Documentation Committee Subjective Score (IKDC)
Baseline
|
47.4 score on a scale
Interval 42.5 to 52.3
|
.909 score on a scale
Interval -6.3 to 7.0
|
|
Subjective International Knee Documentation Committee Subjective Score (IKDC)
1 Month
|
58.4 score on a scale
Interval 52.5 to 64.4
|
58.5 score on a scale
Interval 53.0 to 64.1
|
|
Subjective International Knee Documentation Committee Subjective Score (IKDC)
3 Months
|
61.6 score on a scale
Interval 56.2 to 67.1
|
63.6 score on a scale
Interval 58.6 to 68.7
|
|
Subjective International Knee Documentation Committee Subjective Score (IKDC)
6 Months
|
65 score on a scale
Interval 58.5 to 71.5
|
63.7 score on a scale
Interval 57.6 to 69.7
|
|
Subjective International Knee Documentation Committee Subjective Score (IKDC)
9 Months
|
63.1 score on a scale
Interval 56.3 to 69.9
|
63.7 score on a scale
Interval 57.4 to 70.0
|
|
Subjective International Knee Documentation Committee Subjective Score (IKDC)
12 Months
|
63.7 score on a scale
Interval 57.2 to 70.1
|
64.3 score on a scale
Interval 58.3 to 70.3
|
Adverse Events
Platelet Rich Plasma (PRP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bone Marrow Concentrate (BMC)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Platelet Rich Plasma (PRP)
n=41 participants at risk
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.
|
Bone Marrow Concentrate (BMC)
n=49 participants at risk
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.
|
|---|---|---|
|
General disorders
Patient Hospitalized due to Unrelated Ailments
|
0.00%
0/41 • 2 years
|
2.0%
1/49 • Number of events 1 • 2 years
|
|
Immune system disorders
Patient Withdrawn due to Unrelated Ailments
|
0.00%
0/41 • 2 years
|
2.0%
1/49 • Number of events 1 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place