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Stem Cell Therapy

NANOVAE for Knee Osteoarthritis

Phase 1 & 2

Waitlist Available

Research Sponsored by Nova Vita Laboratory

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with VAS pain score ≥40 mm on screening day will be included

Subjects have a diagnosis of OA in at least one knee defined as Grade II or III on Kellgren-Lawrence (K-L) grading scale which is confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10o caudal beam angulation

Must not have

Subjects have evidence of significant and unstable cardiac dysfunction, e.g. acute myocardial infarction and hypertension with uncontrolled blood pressure over 140/90 will be excluded

Subjects with a history of clotting disorder, anticoagulation therapy that cannot be stopped as prior to infusion will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1, 3, 6, and 12 after infusions

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and potential effectiveness of using an Allogenic Human Amniotic Fluid product called NANOVAE to treat knee osteoarthritis. Osteoarthritis

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here; however, common reactions to injections may include pain at the injection site, swelling, infection risk increase, and allergic reactions. The specific side effects of NANOVAE will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain level is high, scoring 40 or more on the pain scale.

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I have been diagnosed with moderate to severe knee arthritis.

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I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled high blood pressure or recent major heart issues.

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I do not have a clotting disorder and can stop anticoagulation therapy before infusion.

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My diabetes is well-controlled, with A1C ≤ 7.5 and fasting glucose ≤ 200 in the last 6 months.

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I am not on dialysis and do not have uncontrolled kidney disease.

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I do not have rheumatoid arthritis, psoriatic arthritis, or any auto-immune disorders causing knee pain.

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I am willing to stop taking my osteoarthritis pain medication for 7 days before any visit.

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I am not on a waiting list for an organ transplant.

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I haven't had a cortisone injection in the last 3 months.

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I do not have an autoimmune disorder that needs treatment with immunosuppressants.

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I have not had, nor plan to have, knee surgery on the affected knee within a year.

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My knee pain is not due to severe internal damage or swelling.

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My liver functions are within normal ranges.

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I have not needed antibiotics for an infection in the last 2 weeks.

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I am not on anticoagulant therapy, except for Plavix or Aspirin.

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I am able to complete all required tests for the study.

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I am a woman who could become pregnant and am not using birth control.

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I do not have conditions like epilepsy, Parkinson's, dementia, or ALS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1, 3, 6, and 12 after infusions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1, 3, 6, and 12 after infusions

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, 3, 6, and 12 after infusions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NANOVAE administered intraarticular in subjects

Secondary study objectives

Change in "Timed Up and Go" Test

Change in Range of Motion (ROM)

Change in Serum and/or Synovial Biomarkers

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (Randomized, double blinded placebo control)Experimental Treatment2 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 Treatment1 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.

0 / 20Eligibility criteria met