Cell Therapy for Knee Osteoarthritis

Overseen By Michael P Hutchinson, DVM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VivaTech International, Inc.

Must not be taking: Strong opioids, Corticosteroids, NSAIDs

Disqualifiers: Cancer, Cardiovascular, Stroke, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 months

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to determine their effectiveness in reducing pain and inflammation from knee osteoarthritis. One group receives Platelet Rich Plasma (PRP), while the other receives a combination of StroMed and PRP. The trial aims to assess the safety and effectiveness of these treatments for individuals who have experienced knee pain for more than six months due to osteoarthritis. Ideal candidates include those with osteoarthritis from wear and tear or an old injury, experiencing significant knee pain. Participants must follow the treatment plan and attend regular check-ups. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancing osteoarthritis treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Platelet Rich Plasma (PRP) therapy is generally safe for treating knee osteoarthritis. One study found that PRP significantly reduced pain scores from 53.5 to 35.8 after six months, indicating it is well-tolerated with few serious side effects.

The combination of StroMed and PRP also shows promise. A study found that this combination reduced knee pain and improved joint function. These treatments appear well-tolerated, with no major safety concerns reported.

These findings suggest a strong safety record, but participants should always discuss potential risks with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for knee osteoarthritis because they utilize innovative approaches that could offer new benefits compared to traditional options like pain relievers, corticosteroid injections, or physical therapy. Platelet Rich Plasma (PRP) therapy leverages the body's own healing factors, taken from a sample of the patient's blood, to potentially reduce inflammation and enhance tissue repair. Meanwhile, the combination of StroMed with PRP introduces a regenerative cell component, aiming to further boost the healing process by promoting the repair of damaged cartilage. These treatments could potentially provide longer-lasting relief and improved joint function, addressing the root cause of pain rather than just the symptoms.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Studies have shown that platelet-rich plasma (PRP) therapy can significantly reduce knee pain in people with osteoarthritis. One study found that PRP improved pain scores from 53.5 to 35.8 over six months. Many patients experience pain relief for 6 to 12 months after PRP treatment, with a 60% to 70% chance of success. In this trial, one group of participants will receive PRP therapy, while another group will receive a combination of StroMed with PRP. Studies have shown that this combination further reduces knee pain and improves joint function. Some research suggests that it also increases cartilage thickness, which is important for joint health. Overall, evidence suggests these treatments can effectively manage knee osteoarthritis symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Mark LoDico, MD

Principal Investigator

Advanced Regenerative Medicine

Are You a Good Fit for This Trial?

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

Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT

My kidney function is good, with creatinine levels at or below 1.5 mg/dl.

Exclusion Criteria

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

I had a mini-stroke within the last 6 months.

Patients with Body Mass Index (BMI) > 40kg/m2

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Platelet Rich Plasma (PRP)
• StroMed + Platelet Rich Plasma (PRP)

Trial Overview

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.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 2 Interventions

Interventions assigned by Principal Investigator

Group II: Cohort 1 Experimental Treatment 2 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

Who Is Running the Clinical Trial?

VivaTech International, Inc.

Lead Sponsor

Trials

3

Recruited

12,000+

Published Research Related to This Trial

A meta-analysis of 31 clinical trials involving 2705 subjects showed that platelet-rich plasma (PRP) injections significantly improve pain and function in patients with knee osteoarthritis, regardless of the disease stage.

The study found that PRP was particularly effective in early to moderate stages of knee OA, with significant pain relief and functional improvement noted in patients classified as Kellgren-Lawrence stages 1-4.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Vilchez-Cavazos, F., Blázquez-Saldaña, J., Gamboa-Alonso, AA., et al.[2023]

Platelet-rich plasma (PRP) significantly stimulates the proliferation of cells from human knee joint tissues and enhances the secretion of superficial zone protein (SZP), which is crucial for cartilage lubrication.

PRP demonstrates effective lubricating properties on bovine articular cartilage, reducing friction to levels comparable to synovial fluid, which supports its potential efficacy in treating osteoarthritis in the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. Sakata, R., McNary, SM., Miyatake, K., et al.[2022]

Platelet-rich plasma (PRP) therapy is a feasible and minimally invasive treatment for knee osteoarthritis, showing improvements in pain and patient satisfaction among 12 participants who completed the study.

The study reported no serious adverse events, indicating that PRP injections are safe, with only one patient experiencing mild pain and stiffness after the first injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma (PRP) therapy for knee arthritis: a feasibility study in primary care. Glynn, LG., Mustafa, A., Casey, M., et al.[2023]

PTP-001, a novel placental tissue particulate, contains significantly higher levels of key growth factors compared to both leukocyte-rich and leukocyte-poor platelet-rich plasma (PRP), suggesting a potentially more effective treatment for knee osteoarthritis.

Both PTP-001 and PRP can reduce inflammation in cell cultures, but PTP-001 shows more consistent results and greater efficacy in reducing harmful gene expressions related to cartilage degradation, indicating its superior therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis. Flannery, CR., Buddin, KE., Begum, L., et al.[2023]

In a study involving 36 guinea pigs with knee osteoarthritis, multiple injections of platelet-rich plasma (PRP) showed sustained anti-inflammatory effects on the synovium over the long term, unlike a single injection which only had short-term benefits.

While both single and multiple PRP injections improved synovial health, only the multiple injections provided significant chondroprotective effects in the short term, highlighting the potential need for multiple treatments in managing early osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chouhan, DK., Dhillon, MS., Patel, S., et al.[2020]

In a study involving 62 participants with knee osteoarthritis, neither platelet-rich plasma (PRP) nor plasma showed significant improvement in pain or function compared to a saline placebo over 24 weeks.

The PRP group experienced a higher rate of mild adverse events, with 65% reporting increased pain, indicating that while PRP is a minimally invasive treatment, it may not be safer or more effective than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. Dório, M., Pereira, RMR., Luz, AGB., et al.[2022]

In a preliminary study of 14 patients with knee osteoarthritis, intraarticular platelet-rich plasma (PRP) injections showed significant improvements in pain and function, with no reported adverse events, indicating a favorable safety profile.

Patients experienced almost linear improvements in their Knee Injury and Osteoarthritis Outcome Scores over 12 months, suggesting that PRP may effectively relieve symptoms of osteoarthritis and warrant further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Sampson, S., Reed, M., Silvers, H., et al.[2022]

A systematic review of 5 randomized controlled trials involving 301 patients found that a single injection of platelet-rich plasma (PRP) is as effective as multiple injections for reducing pain in knee osteoarthritis over a 6-month period.

However, multiple PRP injections showed a significant improvement in knee functionality compared to a single injection, particularly when comparing single versus triple injections, indicating that while pain relief may be similar, functionality benefits from more frequent treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Vilchez-Cavazos, F., Millán-Alanís, JM., Blázquez-Saldaña, J., et al.[2022]

Platelet-rich plasma (PRP) therapy significantly reduces pain and improves knee function in patients with knee osteoarthritis compared to placebo and other conservative treatments, as shown by lower VAS and WOMAC scores at 6 months post-treatment.

PRP therapy is as safe as placebo and hyaluronic acid (HA), with no significant differences in adverse event rates, making it a viable option for managing knee osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intra-Articular Platelet-Rich Plasma in Osteoarthritis Knee: A Systematic Review and Meta-Analysis. Hong, M., Cheng, C., Sun, X., et al.[2022]

In a phase I clinical trial involving 20 patients with mild to moderate knee osteoarthritis, intra-articular injection of platelet-rich plasma (PRP) was found to be safe and resulted in significant and lasting improvements in pain and function over 12 months, outperforming hyaluronic acid (HA) injections.

While both PRP and HA injections alleviated symptoms of knee osteoarthritis, PRP provided greater improvements in patient-reported outcomes and physical examinations, with benefits lasting longer than those seen with HA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jalali Jivan, S., Monzavi, SM., Zargaran, B., et al.[2022]

Citations

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Analyzing the performance of platelet-rich plasma and ...

Many of our patients with knee OA report from 6 to 12 months of pain relief after treatment with PRP. We usually see a 60% to 70% chance of success.

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PRP therapy significantly improved the VAS scores from 53.5 at baseline to 35.8 at 6 months (P < 0.05). Patients with Kellgren-Lawrence (KL) grade 4 showed less ...

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The administration of three or five injections of platelet-rich plasma is safe, substantially more effective than single injections, and leads to remarkable ...

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