Platelet Rich Plasma Injections In Young And Old Human Subjects

NCT06451120 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 22-38279
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Osteoarthritis; Articular Cartilage; Musculoskeletal Disorders

Keywords

Platelet-rich plasma (PRP)

Outcome Measures

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.

  2 weeks

Secondary Outcomes (1)

• To determine the Intra-individual change in specific proteins in the peripheral blood

  12 weeks

Other Outcomes (4)

• To determine the Protein Changes in the synovial vluid

  2 weeks and 12 weeks

• Examine Differences by Age

  2 weeks and 12 weeks

• Change in Visual Analog Pain Scores

  2 weeks, 12 weeks and 26 weeks

Study Arms (2)

Platelet-rich plasma (PRP)

EXPERIMENTAL

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.

Drug: Platelet-Rich Plasma (PRP) Injections; Device: Centrifuge

Control saline injection (wait-list control)

PLACEBO COMPARATOR

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.

Drug: Platelet-Rich Plasma (PRP) Injections; Drug: Control saline injection

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

Also known as: platelet-rich growth factors (GFs), platelet-rich fibrin (PRF) and platelet concentrates (PCs)

Control saline injection (wait-list control); Platelet-rich plasma (PRP)

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.

Also known as: Microcentrifuge tubes, Eppendorf tubes

Platelet-rich plasma (PRP)

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.

Control saline injection (wait-list control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• English-speaking

You may not qualify if:

• \. Patients will be excluded if:
• 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
• High tibial osteotomy, partial knee replacement, patellar resurfacing), total knee replacement or existing surgical hardware in the knee
• Patient with platelet disorders, bleeding disorder
• Patient with rheumatologic disease, automimmune disorder, immunocompromised status, active history of cancer
• Patient taking Chemotherapy, need for regular prednisone or antiinflammatory used
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94158, United States

RECRUITING

Related Publications (10)

• Van Blarigan EL, Kenfield SA, Olshen A, Panchal N, Encabo K, Tenggara I, Graff RE, Bang AS, Shinohara K, Cooperberg MR, Carroll PR, Jones LW, Winters-Stone K, Luke A, Chan JM. Effect of a Home-based Walking Intervention on Cardiopulmonary Fitness and Quality of Life Among Men with Prostate Cancer on Active Surveillance: The Active Surveillance Exercise Randomized Controlled Trial. Eur Urol Oncol. 2024 Jun;7(3):519-526. doi: 10.1016/j.euo.2023.10.012. Epub 2023 Oct 29.

  PMID: 37907387 BACKGROUND

• Schroer AB, Ventura PB, Sucharov J, Misra R, Chui MKK, Bieri G, Horowitz AM, Smith LK, Encabo K, Tenggara I, Couthouis J, Gross JD, Chan JM, Luke A, Villeda SA. Platelet factors attenuate inflammation and rescue cognition in ageing. Nature. 2023 Aug;620(7976):1071-1079. doi: 10.1038/s41586-023-06436-3. Epub 2023 Aug 16.

  PMID: 37587343 BACKGROUND

• Van Blarigan EL, Chan JM, Sanchez A, Zhang L, Winters-Stone K, Liu V, Macaire G, Panchal N, Graff RE, Tenggara I, Luke A, Simko JP, Cooperberg MR, Carroll PR, Kenfield SA. Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II). Contemp Clin Trials. 2023 Feb;125:107079. doi: 10.1016/j.cct.2023.107079. Epub 2023 Jan 5.

  PMID: 36621597 BACKGROUND

• Langlais CS, Chen YH, Van Blarigan EL, Chan JM, Ryan CJ, Zhang L, Borno HT, Newton RU, Luke A, Bang AS, Panchal N, Tenggara I, Schultz B, Lavaki E, Pinto N, Aggarwal R, Friedlander T, Koshkin VS, Harzstark AL, Small EJ, Kenfield SA. Quality of life for men with metastatic castrate-resistant prostate cancer participating in an aerobic and resistance exercise pilot intervention. Urol Oncol. 2023 Mar;41(3):146.e1-146.e11. doi: 10.1016/j.urolonc.2022.11.016. Epub 2022 Dec 15.

  PMID: 36528473 BACKGROUND

• Kenfield SA, Van Blarigan EL, Panchal N, Bang A, Zhang L, Graff RE, Chen YH, Ryan CJ, Luke A, Newton RU, Tenggara I, Schultz B, Wang E, Lavaki E, Zuniga K, Pinto N, Borno H, Aggarwal R, Friedlander T, Koshkin VS, Harzstark A, Small E, Chan JM. Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. Cancer Med. 2021 Nov;10(22):8058-8070. doi: 10.1002/cam4.4324. Epub 2021 Oct 12.

  PMID: 34636156 BACKGROUND

• Tangtiphaiboontana J, Figoni AM, Luke A, Zhang AL, Feeley BT, Ma CB. The effects of nonsteroidal anti-inflammatory medications after rotator cuff surgery: a randomized, double-blind, placebo-controlled trial. J Shoulder Elbow Surg. 2021 Sep;30(9):1990-1997. doi: 10.1016/j.jse.2021.05.018. Epub 2021 Jun 24.

  PMID: 34174448 BACKGROUND

• Lazaro RM, Souza RB, Luke AC. Patellar mobility and lower limb kinematics during functional activities in individuals with and without patellar tendinopathy. Knee. 2021 Jun;30:241-248. doi: 10.1016/j.knee.2021.04.002. Epub 2021 May 3.

  PMID: 33957465 BACKGROUND

• Krabak BJ, Roberts WO, Tenforde AS, Ackerman KE, Adami PE, Baggish AL, Barrack M, Cianca J, Davis I, D'Hemecourt P, Fredericson M, Goldman JT, Harrast MA, Heiderscheit BC, Hollander K, Kraus E, Luke A, Miller E, Moyer M, Rauh MJ, Toresdahl BG, Wasfy MM. Youth running consensus statement: minimising risk of injury and illness in youth runners. Br J Sports Med. 2021 Mar;55(6):305-318. doi: 10.1136/bjsports-2020-102518. Epub 2020 Oct 29.

  PMID: 33122252 BACKGROUND

• Lau BC, Motamedi D, Luke A. Use of Pocket-Sized Ultrasound Device in the Diagnosis of Shoulder Pathology. Clin J Sport Med. 2020 Jan;30(1):20-24. doi: 10.1097/JSM.0000000000000577.

  PMID: 31855908 BACKGROUND

• Mah CD, Sparks AJ, Samaan MA, Souza RB, Luke A. Sleep restriction impairs maximal jump performance and joint coordination in elite athletes. J Sports Sci. 2019 Sep;37(17):1981-1988. doi: 10.1080/02640414.2019.1612504. Epub 2019 May 24.

  PMID: 31122131 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Musculoskeletal Diseases

Interventions

Injections; Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Anthony Luke, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Luke, MD, MPH

CONTACT

415.502.4548; anthony.luke@ucsf.edu

Jocelyn Carpio

CONTACT

jocelyn.carpio@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 yrs).

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): February 16, 2027
• Study Completion (Estimated): February 16, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)