NANOVAE for Knee Osteoarthritis

Overseen By Trillitye Paullin, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Nova Vita Laboratory

Must not be taking: Anticoagulants, Immunosuppressives, Systemic steroids

Disqualifiers: Cardiac dysfunction, Diabetes, Autoimmune disorders, Liver dysfunction, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and potential benefits of NANOVAE, a treatment derived from amniotic fluid, for individuals with knee osteoarthritis. The researchers seek to determine if this new approach can reduce pain and improve knee function. Participants may receive either the actual treatment or a placebo (inactive substance) for comparison. Those who have experienced knee osteoarthritis pain and have tried standard treatments like physical therapy or anti-inflammatory medications in the past year might be suitable candidates. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires participants to stop taking prescription or over-the-counter pain medication for osteoarthritis for 7 days before any visit. However, you can continue taking medications for other conditions, except those listed under 'Concomitant Medication.'

Is there any evidence suggesting that NANOVAE is likely to be safe for humans?

Research on treatments like NANOVAE, including amniotic suspension allografts, has shown they are generally safe. Past studies reported no major side effects with injections of amniotic tissue, and all safety data remained within normal lab ranges. This suggests that treatments using human amniotic fluid, such as NANOVAE, are well-tolerated. However, since this trial is in the early stages, closely monitoring participants remains crucial to ensure no unexpected side effects occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee osteoarthritis?

Most treatments for knee osteoarthritis, like NSAIDs or corticosteroid injections, focus on managing symptoms rather than addressing underlying tissue issues. Unlike these standard options, NANOVAE is derived from acellular allogenic human amniotic fluid (hAF), which is rich in growth factors that may promote tissue repair and regeneration. Researchers are excited about NANOVAE because it offers a potential new mechanism of action by directly supporting joint health and potentially slowing disease progression, rather than just masking pain.

What evidence suggests that NANOVAE might be an effective treatment for knee osteoarthritis?

Research suggests that amniotic fluid, like the one used in NANOVAE, might help with knee osteoarthritis (KOA) by reducing inflammation. In previous studies, tiny molecules in amniotic fluid, called microRNAs, have been linked to less joint damage and inflammation, which are major problems in osteoarthritis. A small study with a similar product showed that a single injection was safe and suggested possible relief from symptoms like pain and stiffness. In this trial, participants in Group 1 will receive NANOVAE to assess safety, while Group 2 will be randomized to receive either NANOVAE or a placebo. Although more research is needed, the hope is that NANOVAE might offer similar benefits by addressing the inflammation and tissue damage that cause KOA. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis, a joint condition causing pain and stiffness. Participants should be middle-aged or older as this group commonly experiences OA. Specific eligibility criteria are not provided, but typically include having symptoms of KOA and being in generally stable health.

Inclusion Criteria

Subjects must be available for all specified assessments at the study site through the completion of the study

Patient may be eligible for treatment of both knees if criteria is met for both

Study subjects must be willing to give written informed consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed

Exclusion Criteria

I am not planning to use steroids during the study, except for COVID-19 or a non-arthritic flare-up.

I have received a solid organ transplant and have experienced rejection.

I haven't had a hyaluronic acid injection in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Label Safety Assessment

Group 1 subjects receive a single dose of NANOVAE and are assessed for safety at seven-day intervals

5 days

1 visit (in-person), 1 follow-up (virtual or in-person)

Randomized Treatment

Group 2 subjects receive two doses of NANOVAE or placebo, with follow-up assessments

15 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person) at Months 1, 3, 6, and 12

What Are the Treatments Tested in This Trial?

Interventions

• NANOVAE - Acellular Allogenic Human Amniotic Fluid (hAF)

Trial Overview The study tests NANOVAE (Allogenic Human Amniotic Fluid) against a placebo (0.9% Sodium Chloride Injection). It's a phase I/II trial to assess safety and potential effectiveness when injected into the knee joint of those with osteoarthritis, comparing outcomes between the two groups.

How Is the Trial Designed?

Group I: Group 2 (Randomized, double blinded placebo control) Experimental Treatment 2 Interventions

Total of sixteen subjects will be randomized to either receive two doses of NANOVAE via intraarticular injections or receive two doses of a placebo. Dose - 2 mL of NANOVAE or placebo on day 0 and day 15, containing 1 x 1011 particles/ml. The ratio is 1:1 for a total of 16 subjects in the Group 2. Product will be administered directly without any dilution.

Group II: Group 1 (Open Label) Experimental Treatment 1 Intervention

A total of eight subjects will be treated to assess safety prior to enrolling Group 2. We propose to assess the safety of 8 subjects in Group 1 at seven-day intervals. Each subject in Group 1 will be staggered by 5 days after receiving the dose of NANOVAE. Dose - 2 mL of NANOVAE on day 0 containing 1.0 x 1011 to 9.0 x 1011 particles/ml. Product will be administered directly without any dilution.

Who Is Running the Clinical Trial?

Nova Vita Laboratory

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a multicenter randomized controlled trial involving 200 subjects with knee osteoarthritis, amniotic suspension allograft (ASA) treatment resulted in significantly greater improvements in pain and function compared to both hyaluronic acid (HA) and saline treatments over 3 and 6 months.

Only 13.2% of patients receiving ASA reported unacceptable pain at 3 months, compared to 68.8% in the HA group and 75% in the saline group, indicating ASA's potential as an effective nonoperative management option for symptomatic knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. Farr, J., Gomoll, AH., Yanke, AB., et al.[2020]

In a rat model of knee osteoarthritis, injections of amniotic suspension allograft (ASA) significantly improved pain thresholds, gait, and overall function, indicating its potential efficacy as a nonsurgical treatment.

The study found that ASA treatment led to increased cartilage thickness and anti-inflammatory cytokines without causing adverse effects, suggesting it is a safe option for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic suspension allograft improves pain and function in a rat meniscal tear-induced osteoarthritis model. Kimmerling, KA., Gomoll, AH., Farr, J., et al.[2022]

A feasibility study involving 6 patients with severe knee osteoarthritis showed that a single injection of human amniotic suspension allografts (ASA) was safe, with no significant adverse reactions or effects on blood cell counts and inflammatory markers over 12 months.

Patient-reported outcomes indicated a potential benefit from the ASA treatment, supporting the need for a larger placebo-controlled trial to further evaluate its efficacy in managing symptoms of knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. Vines, JB., Aliprantis, AO., Gomoll, AH., et al.[2017]

Citations

1. ctv.veeva.com ctv.veeva.com/study/nanovae-to-treat-knee-osteoarthritis-koa

NANOVAE to Treat Knee Osteoarthritis (KOA) The below summarizes relevant information for investigator(s) to consider the use of Allogenic Human Amniotic Fluid product in a clinical ...

2. withpower.com withpower.com/trial/nanovae-for-knee-osteoarthritis-f74ac

NANOVAE for Knee Osteoarthritis · Info for Participants A feasibility study involving 6 patients with severe knee osteoarthritis showed that a single injection of human amniotic suspension allografts (ASA) was safe, ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06606561/

Trial | NCT06606561 The below summarizes relevant information for investigator(s) to consider the use of Allogenic Human Amniotic Fluid product in a clinical protocol detailing ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-nanovae-to-treat-knee-osteoarthritis-koa-trial-nct06606561

NANOVAE to Treat Knee Osteoarthritis (KOA) Benefits: Participation in this study may provide potential relief from knee osteoarthritis symptoms, such as pain, stiffness, and reduced functionality.

5. novavitalabs.com novavitalabs.com/our-science

Our Science - Research & Technology Nova Vita Labs is launching a groundbreaking clinical trial to evaluate the efficacy and safety of NANOVAE – an acellular minimally manipulated allogenic human ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9031613/

Allogenic Amniotic Tissue for Treatment of Knee and Hip ... No major adverse events were reported related to injection of amniotic tissue, and all the safety data was within the reference range of the laboratory during ...