Platelet Rich Plasma Injections In Young And Old Human Subjects

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06451120
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Platelet-Rich Plasma (PRP) Injections — DRUG
    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
  • Centrifuge — DEVICE
    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.
  • Control saline injection — DRUG
    A 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Mar 2026
Primary completion
Feb 16, 2027
Completion
Feb 16, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Platelet-rich plasma (PRP)
    A vacutainer vial containing 50 mL of peripheral blood will be processed immediately to create PRP using a previously optimized two-step centrifugation protocol viii. First, the whole blood will be centrifuged at 500 x g for 8 minutes at 4°C. The plasma will be collected above the buffy coat using a sterile pipette, placed into a separate sterile tube, and centrifuged a second time at 700 x g for 17 minutes at 12° C. The top 70% will be collected as the PPP and the bottom 30% will be resuspended as the PRP. PPP will be aliquoted into cryovials for storage at -80 °C. Approximately 6 mL of PRP will be produced from each 50 mL vial of whole blood. Five mL will be allocated for administration to patients and the remaining one mL will be aliquoted into cryovials for storage at -80 °C. The syringe containing PRP will be covered with Aluminum foil, such that the investigator cannot tell what fluid is to be injected.
  • Placebo Comparator: Control saline injection (wait-list control)
    A 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.

Primary Outcome Measure

Identify Protein Changes in Platelet Rich Plasma (PRP) [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94158
Anthony Luke, MD, MPH
[email protected]
415-514-6120
Jocelyn Carpio
[email protected]
4155024548

Find similar trials in San Francisco, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
University of California· San Francisco, CA

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