Cell Therapy for Knee Osteoarthritis
Recruiting in Palo Alto (17 mi)
Overseen byMark LoDico, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: VivaTech International, Inc.
Must not be taking: Strong opioids, Corticosteroids, NSAIDs
Disqualifiers: Cancer, Cardiovascular, Stroke, Hepatitis, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.
Will I have to stop taking my current medications?
The trial requires that you stop using strong opioid drugs for other pain at least 4 weeks before joining and avoid corticosteroid injections at the treatment site for 1 month prior. You also need to stop using NSAIDs (non-steroidal anti-inflammatory drugs) consistently within 48 hours of the procedure.
What data supports the effectiveness of this treatment for knee osteoarthritis?
Research suggests that platelet-rich plasma (PRP) therapy, which involves using a concentration of growth factors from a patient's own blood, may help reduce symptoms of knee osteoarthritis by improving lubrication in the joint and reducing inflammation.
12345Is platelet-rich plasma (PRP) therapy safe for treating knee osteoarthritis?
Research indicates that platelet-rich plasma (PRP) therapy is generally considered a safe treatment for knee osteoarthritis, with studies reporting it as a minimally invasive and safe biological approach.
13678How is the treatment of PRP and StroMed for knee osteoarthritis different from other treatments?
The treatment using Platelet Rich Plasma (PRP) and StroMed is unique because it involves using a patient's own blood components to potentially improve knee function and reduce pain, offering a minimally invasive alternative to standard treatments like hyaluronic acid injections. PRP contains growth factors that may help in cartilage lubrication and repair, which is not a feature of many conventional treatments.
134910Eligibility Criteria
This trial is for adults aged 18-90 with knee pain from osteoarthritis (grade 2 or higher) for over 6 months. Participants should have good immune, kidney, blood coagulation, heart and lung function. Excluded are those with recent steroid injections or strokes, heavy NSAID use before the procedure, certain cancers within 5 years, severe obesity (BMI >40), infections including hepatitis B/C or HIV, gout conditions and strong opioid use recently.Inclusion Criteria
Patients must be able to comply with treatment plan, laboratory tests, and periodic interviews
I am between 18 and 90 years old.
Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT
+5 more
Exclusion Criteria
I had a mini-stroke within the last 6 months.
Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
Patients with Body Mass Index (BMI) > 40kg/m2
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive autologous Stromed and PRP treatments for Osteoarthritis of the knee
2 months
Initial treatment, plus follow-up treatments at 1 week, 2 weeks, 1 month, and 2 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI, laboratory tests, and surveys
6 months
Follow-up MRI and assessments at 0, 2, and 6 months
Extension
Optional follow-up for additional monitoring and assessment of long-term outcomes
6-12 months
Participant Groups
The study tests the safety and effectiveness of autologous cell therapy using StroMed combined with platelet rich plasma (PRP) versus PRP alone in reducing knee pain and inflammation due to osteoarthritis. It's an open-label trial starting with 50 patients followed by a larger group of up to 4,000 participants.
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment2 Interventions
Interventions assigned by Principal Investigator
Group II: Cohort 1Experimental Treatment2 Interventions
Interventions assigned by Principal Investigator
Platelet Rich Plasma (PRP) is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Platelet-rich plasma for:
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
🇪🇺 Approved in European Union as Platelet-rich plasma for:
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
🇨🇦 Approved in Canada as Platelet-rich plasma for:
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
🇯🇵 Approved in Japan as Platelet-rich plasma for:
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VivaTech International, Inc.Grove City, PA
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Who Is Running the Clinical Trial?
VivaTech International, Inc.Lead Sponsor
References
Platelet-rich plasma (PRP) therapy for knee arthritis: a feasibility study in primary care. [2023]Platelet-rich plasma (PRP) is a concentrate of autologous blood growth factors which has been shown to provide some symptomatic relief in early osteoarthritis (OA) of the knee. The objective of this study was to test the feasibility and efficacy potential of platelet rich plasma (PRP) in primary care.
Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]To evaluate the clinical effects of intraarticular platelet-rich plasma (PRP) injections in a small group of patients with primary and secondary osteoarthritis. Most of the current treatments for osteoarthritis are palliative and attack the symptoms rather than influencing the biochemical environment of the joint. Autologous platelet-rich plasma has emerged as a treatment option for tendinopathies and chronic wounds. In addition to release of growth factors, platelet-rich plasma also promotes concentrated anti-inflammatory signals including interleukin-1ra, which has been a focus of emerging treatments for osteoarthritis.
Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. [2022]Platelet-rich plasma (PRP) has a still conflicting efficacy for knee osteoarthritis (KOA) and might be a minimally invasive and safe treatment alternative. The potential benefit of only plasma (non-enriched) has never been investigated. Our aim was to evaluate the efficacy of intra-articular platelet-rich plasma (PRP) and plasma to improve pain and function in participants with KOA over 24 weeks.
Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. [2022]Platelet-rich plasma (PRP) contains high concentrations of autologous growth factors that originate from platelets. Intra-articular injections of PRP have the potential to ameliorate the symptoms of osteoarthritis in the knee. Superficial zone protein (SZP) is a boundary lubricant in articular cartilage and plays an important role in reducing friction and wear and therefore is critical in cartilage homeostasis.
Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis. [2023]This study was conducted to compare therapeutically relevant properties of platelet-rich plasma (PRP), a commonly used autologous intra-articular treatment for osteoarthritis (OA), with those of a novel placental tissue particulate, PTP-001, which is in development as a regulated biologic treatment for knee OA.
Comparison of the Clinical Effectiveness of Single Versus Multiple Injections of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-analysis. [2022]Reports have concluded that platelet-rich plasma (PRP) is an effective and safe biological approach in the treatment of knee osteoarthritis (OA). However, no consensus has been established regarding the number of injections required to observe a therapeutic effect.
The use of platelet-rich plasma in studies with early knee osteoarthritis versus advanced stages of the disease: a systematic review and meta-analysis of 31 randomized clinical trials. [2023]Reports have concluded that platelet-rich plasma (PRP) is an effective and safe biological approach to treating knee osteoarthritis (OA). However, the effectiveness of PRP in advanced stages of the disease is not entirely clear. The purpose of this study was to evaluate whether the use of PRP would be as effective in studies with early-moderate knee OA patients compared to studies including patients with end-stage OA, based on the Kellgren-Lawrence classification.
Efficacy and Safety of Intra-Articular Platelet-Rich Plasma in Osteoarthritis Knee: A Systematic Review and Meta-Analysis. [2022]Knee osteoarthritis (KOA) is a common disease in aged adults. Intra-articular (IA) injection of platelet-rich plasma (PRP) therapy is an effective minimally invasive treatment for KOA. We aimed to compare the efficacy and safety of platelet-rich plasma (PRP) with placebo or other conservative treatments.
Comparative Analysis of the Effectiveness of Intra-Articular Injection of Platelet-Rich Plasma versus Hyaluronic Acid for Knee Osteoarthritis: Results of an Open-Label Trial. [2022]Platelet-rich plasma (PRP), an autologous source of growth factors, and hyaluronic acid (HA) are among the minimally invasive treatments for knee osteoarthritis (OA). This trial was designed to compare the effectiveness of intra-articular injection of PRP with HA (as one of the standard treatments) on mild to moderate knee OA.
Multiple Platelet-Rich Plasma Injections Versus Single Platelet-Rich Plasma Injection in Early Osteoarthritis of the Knee: An Experimental Study in a Guinea Pig Model of Early Knee Osteoarthritis. [2020]Platelet-rich plasma (PRP) has emerged as the forerunner among disease-modifying treatment options for early osteoarthritis (OA) of the knee. However, no consensus is available regarding optimum dosing schedules.