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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06451120
Other study ID # 22-38279
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2024
Est. completion date December 18, 2025

Study information

Verified date June 2024
Source University of California, San Francisco
Contact Anthony Luke, MD, MPH
Phone 415.502.4548
Email anthony.luke@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Description:

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Study Design


Intervention

Drug:
Platelet-Rich Plasma (PRP) Injections
Bloods 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
Device:
Centrifuge
The 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.

Locations

Country Name City State
United States University of California San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Other 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. 2 weeks and 12 weeks
Other 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. 2 weeks and 12 weeks
Other 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. 2 weeks, 12 weeks and 26 weeks
Other 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. 2 weeks, 12 weeks and 26 weeks
Primary 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. 2 weeks
Secondary 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. 12 weeks
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