Platelet Rich Plasma Injections In Young And Old Human Subjects
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of California, San Francisco
About this trial
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 UCSF's 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Grade 1-3 KL score will be recruited;
Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee;
Have symptomatic complaints from osteoarthritis pain in no other joint affecting the hips, ankles or unaffected knee;
Will be able to attend and perform physical therapy.
Disqualifiers
Received injection therapy for knee osteoarthritis in the past 6 months
Have signs of concomitant osteoarthritis of 1 or more other major joints of the lower extremities that impair their daily activity level
History of septic arthritis
Have underwent a previous knee surgery specifically for osteoarthritis or osteochondral defects less than 1 year before randomization (i.e. autograft or allograft surgery
Trial design
Design model
Crossover
Treatments tested in this trial
Platelet-Rich Plasma (PRP) Injections
DrugBloods will be drawn prior to the PRP injection, and repeated at 2 weeks, 12 weeks, possibly 14 weeks for crossover patients follow up visits. Under aseptic technique with a surgical drape/curtain in place to block the study subject's view of the knee. Syringes will be covered with aluminum foil and subjects will have a cover over their eyes, so that neither subjects nor the clinical investigator will know if the injection delivered is PRP injection or a normal saline injection
Centrifuge
DeviceThe Eppendorf Centrifuge is used to make the PRP. In our opinion, the centrifuge is a nonsignificant risk device. The centrifuge, sterile vials for blood collection and PRP injection syringes do not present a potential risk for serious health, safety or welfare of a subject. It is not needed to support or sustain human life. It is not of substantial importance in diagnosis, curing, mitigating or treating disease for the health, safety and welfare of the patients. There are no potential for serious risk to the health, safety or welfare of a subject.
Control saline injection
DrugA placebo injection of 6 mL of 0.9% saline will be prepared by the unblinded research assistant in an adjacent room. The syringed will be prepared in a 10 mL syringe and covered with Aluminum foil, such that the investigator performing the injection cannot tell if there is PRP or saline to be injected.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Platelet-rich plasma (PRP)Experimental treatment 2 interventions
Group B: Control saline injection (wait-list control)Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Identify Protein Changes in Platelet Rich Plasma (PRP)
The protein changes from a single autologous PRP injection (5 mL) vs normal saline control, using proteomic analysis of' venous blood samples. For proteomic analysis of Platelet poor plasma (PPP) and PRP, the samples will undergo quantitative mass spectrometry, with higher numbers indicating more proteins and lower numbers meaning less proteins.
Time frame
2 weeksSecondary outcomes
1
To determine the Intra-individual change in specific proteins in the peripheral blood
Changes in specific proteins in the blood will be different (e.g., higher or lower) after the 5 mL PRP injection compared to a normal saline control using proteomic analysis. PPP and PRP samples will undergo quantitative mass spectrometry, with higher numbers indicating more proteins and lower numbers meaning less proteins.
Time frame
12 weeksOther outcomes
1
To determine the Protein Changes in the synovial vluid
Using proteomic analysis of the synovial fluid at the knee, compare the protein alterations caused by an autologous PRP dose (5 mL) to the normal saline control. For proteomic analysis of synovial fluid, the samples will undergo quantitative mass spectrometry, with higher numbers indicating more proteins and lower numbers meaning less proteins.
Time frame
2 weeks and 12 weeks2
Examine Differences by Age
Protein alterations in blood and synovial fluid following knee injections. For each arm, investigator will compare groups of young people (18-45 years old) and older people (46-70 years old) independently.
Time frame
2 weeks and 12 weeks3
Change in Visual Analog Pain Scores
Pain will be measured using the Visual Analog Pain Scores, the score ranges from 0-10, zero indicating no pain and 10 being the worst pain ever.
Time frame
2 weeks, 12 weeks and 26 weeks4
Changes in Knee Injury and Osteoarthritis Outcome Scores (KOOS scores)
Knee Injury and Osteoarthritis Outcome Scores (KOOS scores), the score ranges from 0-100, with 0 representing extreme knee problems and 100 representing no knee problems.
Time frame
2 weeks, 12 weeks and 26 weeksSponsors and contacts
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Source ClinicalTrials.gov