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RECRUITING

NCT06451120

PHASE2

Platelet Rich Plasma Injections In Young And Old Human Subjects

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Official title: Study of Platelet Rich Plasma (PRP) Injections With Symptomatic Knee Osteoarthritis for Biomarker Exploration in Young and Old Human Subjects

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-01

Completion Date

2027-02-16

Last Updated

2026-03-19

Healthy Volunteers

Yes

Conditions

Osteoarthritis Articular Cartilage Musculoskeletal Disorders

Interventions

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.

DRUG

Control saline injection

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.

Inclusion Criteria 1. Grade 1-3 KL score will be recruited; 2. Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee; 3. Have symptomatic complaints from osteoarthritis pain in no other joint affecting the hips, ankles or unaffected knee; 4. Will be able to attend and perform physical therapy. 5. English-speaking Exclusion Criteria 1\. Patients will be excluded if: 1. Received injection therapy for knee osteoarthritis in the past 6 months 2. Have signs of concomitant osteoarthritis of 1 or more other major joints of the lower extremities that impair their daily activity level 3. History of septic arthritis 4. Have underwent a previous knee surgery specifically for osteoarthritis or osteochondral defects less than 1 year before randomization (i.e. autograft or allograft surgery 5. High tibial osteotomy, partial knee replacement, patellar resurfacing), total knee replacement or existing surgical hardware in the knee 6. Patient with platelet disorders, bleeding disorder 7. Patient with rheumatologic disease, automimmune disorder, immunocompromised status, active history of cancer 8. Patient taking Chemotherapy, need for regular prednisone or antiinflammatory used 9. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 10. Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to: i. Acute myocardial Infarction (within 5 days of any planned study procedure); ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute (within 3 months) pulmonary embolus or pulmonary infarction; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Room air desaturation at rest ≤85%; xv. Respiratory failure; xvi. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis); and xvii. Mental impairment leading to inability to cooperate.

Locations (1)

University of California

San Francisco, California, United States