Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Brief Title:
Platelet Rich Plasma Injections In Young And Old Human Subjects
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Study of Platelet Rich Plasma PRP Injections With Symptomatic Knee Osteoarthritis for Biomarker Exploration in Young and Old Human Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRP-KOBE
Brief Summary:
This is a randomized double-blind placebo-controlled phase 2 study with a secondary crossover phase at the end of the initial trial to ensure all subjects receive one PRP injection The goal is to identify what proteins change in the blood following repeated intraarticular knee PRP injections in patients with knee osteoarthritis The objective is to determine the protein changes resulting from a single autologous PRP injection 5 mL in comparison to a normal saline control
About 60 subjects will take part in this study by two age groups at UCSF into the following arms Arm A PRP injection Arm B normal saline injection control The study aims to demonstrate what benefits PRP has on knee osteoarthritis and methods to best achieve biologic effects Subjects with a diagnosis of knee osteoarthritis ages 18-45 and 46-70 years old presenting to a University Based sports medicine clinic will be screened for potential eligibility Subjects who meet all qualifying requirements will be recruited from UCSFs orthopedic and primary care clinics
Subjects will be on study for up to 26 weeks Screening up to 14 days Treatment injection of PRP or normal saline subjects can cross over at week 12 to a PRP if originally in the control injection group Follow-up 2 weeks post-baseline injection 12 weeks postbaseline 14 weeks if crossover patient 26 weeks
About 60 subjects will take part in this study by two age groups at UCSF into the following arms Arm A PRP injection Arm B normal saline injection control The study aims to demonstrate what benefits PRP has on knee osteoarthritis and methods to best achieve biologic effects Subjects with a diagnosis of knee osteoarthritis ages 18-45 and 46-70 years old presenting to a University Based sports medicine clinic will be screened for potential eligibility Subjects who meet all qualifying requirements will be recruited from UCSFs orthopedic and primary care clinics
Subjects will be on study for up to 26 weeks Screening up to 14 days Treatment injection of PRP or normal saline subjects can cross over at week 12 to a PRP if originally in the control injection group Follow-up 2 weeks post-baseline injection 12 weeks postbaseline 14 weeks if crossover patient 26 weeks
Detailed Description:
This is a randomized double-blind placebo-controlled trial with a secondary crossover phase at the end of the initial trial to ensure all subjects receive one PRP injection The randomization will be stratified by two age groups ages 18-45 yrs and 46-70 yrsScreening and medical chart data will be reviewed to determine subject eligibility
Platelet rich plasma PRP falls under transfusion medicine which has been FDA approved Seeking to identify biological pathways by which PRP acts in a degenerative condition like knee osteoarthritis The study compares the immediate and delayed variations in blood and synovial fluid biomarkers following PRP knee intraarticular injections in younger and older patients with knee osteoarthritis The differences in blood biomarkers between ages of Knee osteoarthritis KOA patients are being investigated in this study Intra-individual variations in some blood proteins will deviate eg be larger or lower from a normal saline control between week two and week twelve following the 5 mL PRP injection
The unblinded research evaluation will evaluate the first batch of the first 20 blood and synovial fluid samples to ensure that the tests provide the desired results and data outcomes
The visits consist of the Baseline visits Week 0 the Week 2 visit and the Week 12 visit and for half of the participants an optional 14 Week visit These are in person visits There are three remote visits at Week 26 Week 52 and Week 104
Participation is estimated to take 2-25 hours for each visit over 6 months The time it takes for each participant to attend an on-site visit is approximately 2-25 hours in total each time The knee injection takes approximately 45 minutes for blood or knee fluid donation and preparation of the PRP This injection occurs 1-2 times depending on randomization arm Subjects will complete surveys at the 3-4 timepoints estimated to take 30 minutes per timepoint or total perform functional testing which is walking 40 meters back and forth quickly sitting and standing for 30 seconds and climbing stairs for 3 minutes and have the activity monitor put on 15 minutes Subject will complete study questionnaires at the beginning of each visit 30 minutes In addition participants are asked to engage in physical therapy ideally once a week for 10 weeks although this will be documented as it is standardized but not required for the study
If subjects are assigned to the Placebo Arm Arm B subjects will be informed that of receiving the placebo normal saline injection rather than the PRP injection Subject will be offered the option of crossing over to receive a PRP injection If a subject agrees to have a PRP injection researchers will collect research blood about 60cc or 4 tablespoons and fluid from the knee joint space If the subject decides to receive the PRP injection the researchers will collect research blood approximately 20ml or 15 tablespoons and fluid from the knee joint space 45 minutes The subject will fill out a questionnaire 30 minutes and perform tasks to test their function 45 minutes At the baseline appointment subjects will receive an activity monitor to use for one week The activity monitor should be returned on the week 14 visit
Week 14 on site visit - If subjects are given a PRP injection at 12 weeks subjects will have a two-week follow-up visit The researchers will collect research blood about 20ml or 2 tablespoons and fluid from the knee joint space Subjects will complete a questionnaire and tasks testing the subjects function Subjects will go home with an activity monitor that subjects will be asked to wear for 1 week The activity monitor should be returned Subjects will be asked to keep a diary to record symptoms and pain medication intake following injections The participants will be interviewed and have their diaries reviewed on follow up visits
Platelet rich plasma PRP falls under transfusion medicine which has been FDA approved Seeking to identify biological pathways by which PRP acts in a degenerative condition like knee osteoarthritis The study compares the immediate and delayed variations in blood and synovial fluid biomarkers following PRP knee intraarticular injections in younger and older patients with knee osteoarthritis The differences in blood biomarkers between ages of Knee osteoarthritis KOA patients are being investigated in this study Intra-individual variations in some blood proteins will deviate eg be larger or lower from a normal saline control between week two and week twelve following the 5 mL PRP injection
The unblinded research evaluation will evaluate the first batch of the first 20 blood and synovial fluid samples to ensure that the tests provide the desired results and data outcomes
The visits consist of the Baseline visits Week 0 the Week 2 visit and the Week 12 visit and for half of the participants an optional 14 Week visit These are in person visits There are three remote visits at Week 26 Week 52 and Week 104
Participation is estimated to take 2-25 hours for each visit over 6 months The time it takes for each participant to attend an on-site visit is approximately 2-25 hours in total each time The knee injection takes approximately 45 minutes for blood or knee fluid donation and preparation of the PRP This injection occurs 1-2 times depending on randomization arm Subjects will complete surveys at the 3-4 timepoints estimated to take 30 minutes per timepoint or total perform functional testing which is walking 40 meters back and forth quickly sitting and standing for 30 seconds and climbing stairs for 3 minutes and have the activity monitor put on 15 minutes Subject will complete study questionnaires at the beginning of each visit 30 minutes In addition participants are asked to engage in physical therapy ideally once a week for 10 weeks although this will be documented as it is standardized but not required for the study
If subjects are assigned to the Placebo Arm Arm B subjects will be informed that of receiving the placebo normal saline injection rather than the PRP injection Subject will be offered the option of crossing over to receive a PRP injection If a subject agrees to have a PRP injection researchers will collect research blood about 60cc or 4 tablespoons and fluid from the knee joint space If the subject decides to receive the PRP injection the researchers will collect research blood approximately 20ml or 15 tablespoons and fluid from the knee joint space 45 minutes The subject will fill out a questionnaire 30 minutes and perform tasks to test their function 45 minutes At the baseline appointment subjects will receive an activity monitor to use for one week The activity monitor should be returned on the week 14 visit
Week 14 on site visit - If subjects are given a PRP injection at 12 weeks subjects will have a two-week follow-up visit The researchers will collect research blood about 20ml or 2 tablespoons and fluid from the knee joint space Subjects will complete a questionnaire and tasks testing the subjects function Subjects will go home with an activity monitor that subjects will be asked to wear for 1 week The activity monitor should be returned Subjects will be asked to keep a diary to record symptoms and pain medication intake following injections The participants will be interviewed and have their diaries reviewed on follow up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None