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New treatment option for Osteoarthritis
Official title Platelet Rich Plasma Injections In Young And Old Human Subjects
ClinicalTrials.gov ID: NCT06451120
What this study is testing
What is Platelet-Rich Plasma (PRP) Injections?
Platelet-Rich Plasma (PRP) Injections is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for osteoarthritis.
Also referred to as platelet-rich growth factors (GFs), platelet-rich fibrin (PRF) and platelet concentrates (PCs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 26 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join if
- 1\. 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...
- High tibial osteotomy, partial knee replacement, patellar resurfacing), total knee replacement or existing surgical hardware in the knee
See the full eligibility criteria
- 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
- 1\. 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 26 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.