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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 3 6 7 8}

How 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. ^{1 3 4 9 10}

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.

Research Team

Mark LoDico, MD

Principal Investigator

Advanced Regenerative Medicine

Eligibility 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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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) 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma (PRP) therapy for knee arthritis: a feasibility study in primary care. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Stimulation of the superficial zone protein and lubrication in the articular cartilage by human platelet-rich plasma. [2022]

5. United States 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. [2023]

6. United States 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. [2022]

7. Germany 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intra-Articular Platelet-Rich Plasma in Osteoarthritis Knee: A Systematic Review and Meta-Analysis. [2022]

9. Iran 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. [2022]

10. United States 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. [2020]