NANOVAE to Treat Knee Osteoarthritis (KOA)

Part of paid clinical trials in Chesterfield, Missouri.

Sponsor
Nova Vita Laboratory
Study ID
NCT06606561
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NANOVAE - Acellular Allogenic Human Amniotic Fluid (hAF) — DRUG
    A total of 24 subjects meeting all inclusion/exclusion criteria will be divided into two groups. Group 1 will be an open-label lead-in phase. Group 2 will be a randomized, double-blinded, placebo-controlled cohort. Group 1 will receive one dose of 2ml of NANOVAE, and Group 2, in a randomized and double-blinded fashion, will receive two doses of 2ml NANOVAE. Neither the patients nor the researchers will know who is getting the placebo and who is getting the NANOVAE; only the product manufacturing staff will be unblinded. The ratio of placebo to NANOVAE is 1:1 for a total of 16 subjects in Group 2. Only the knee with the more severe symptoms of OA will be treated. The allogenic-HAF
  • 0.9% Sodium Chloride Injection, USP — DRUG
    In lieu of AF, the saline for injection will be used as a placebo. Vials acquired from the manufacturer is pipetted into glass vials, stoppered, capped, placed in labeled header foil pouches, and sealed. These are transferred to a quarantine freezer to await post-production testing.

Study Details

The below summarizes relevant information for investigator(s) to consider the use of Allogenic Human Amniotic Fluid product in a clinical protocol detailing study design and conduct for a phase I/II randomized, double-blinded, placebo-controlled clinical trial to evaluate the safety and potential efficacy of NANOVAE injected intra-articularly in patients suffering from knee osteoarthritis. The IB will be reviewed annually and amended when further information becomes available. Osteoarthritis (OA) is a degenerative disease of the joints that affects millions of people worldwide, yet its exact causes are not fully understood. Middle-aged to elderly individuals are often the most impacted by OA, which primarily affects the knee, hip, spine, and joints in the fingers. Among these, knee osteoarthritis (KOA) is the most common form, causing pain, stiffness, and reduced functionality, and it is a major contributor to chronic bone and muscle pain. It is also a leading cause of disability in adults who are not living in institutions. Treatment for KOA is challenging due to its resistance to medications, procedures, and surgeries. The primary objective is to alleviate pain and enhance overall function. However, since there is currently no cure for OA, the need for an effective therapy remains urgent. Healthcare professionals often encounter patients whose pain may result from an inflammatory response triggered by injury or disease. Research suggests that regenerative medicine, utilizing techniques like stem cells, platelet-rich plasma (PRP), amniotic fluid, and cytokine modulation, holds promise for treating KOA. OA is associated with an increase in pro-inflammatory substances such as interleukin (IL)-1, IL-6, tumor necrosis factor-alpha (TNF-α), matrix metalloproteinases (MMPs), nitric oxide (NO), reactive oxygen species (ROS), and cytokine-inducible cyclooxygenase-2 (COX-2). These inflammatory agents affect various cell types within the affected joints, including chondrocytes, osteoblasts, osteoclasts, synoviocytes, and macrophages. Some miRNAs, which are downregulated in OA, have been identified as protective factors. For example, miR-130 helps regulate TNF-α levels, while miR-149 controls several inflammatory cytokines such as IL-1, IL-6, and TNF-α. The breakdown of the cartilage matrix is a key characteristic of OA. MMP-13, a member of the MMP family, plays a significant role in degrading the collagen network during OA development. Several miRNAs, including miR-27b, miR-27a, miR-148a, miR-320, miR-127-5p, and miR-411, are downregulated in OA and target the mRNA of this proteinase. It is important to note that a single miRNA can regulate multiple target genes associated with OA progression. For instance, miR-105 and miR-148, both downregulated in OA, target genes such as Runx2, ADAMTS4, ADAMTS5, ADAMTS7, ADAMTS12, MMP-13, and COL10, implying their potential protective roles. Several studies have shown a link between certain miRNAs, aging, and the progression of OA. For example, miR-320c is downregulated in aging OA samples and regulates ADAMTS5, suggesting that this miRNA may serve as a protective factor by enhancing chondrogenesis.

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2025
Primary completion
Apr 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (Open Label)
    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.
  • Experimental: Group 2 (Randomized, double blinded placebo control)
    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.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NANOVAE administered intraarticular in subjects [ Time Frame: 30 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bluetail Medical GroupChesterfieldMissouri63005
David Crane, MD
[email protected]
(636) 778-2900

Find similar trials in Chesterfield, MO

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Bluetail Medical Group· Chesterfield, MO

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