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ACTIVE NOT RECRUITING Phase 1

Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis

NCT05835895 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.

Interventions

  • DRUG Placebo
  • GENETIC GNSC-001
  • DRUG transient immune-modulation

Study Locations (9)

Florida

  • Well Pharma Medical Research — Miami
  • South Florida Research — Miami Springs
  • Premier Medical Associates — The Villages

California

  • Biosolutions Clinical Research Center — La Mesa
  • UC San Diego — San Diego

Alabama

  • Alliance for Medical Research Mobile — Mobile

Missouri

  • Alliance for Multispecialty Research Kansas City — Kansas City

North Carolina

  • West Clinical Research — Morehead City

Pennsylvania

  • Altoona Center for Clinical Research — Duncansville

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2023-06-12
Est. Completion 2029-05
Phase Phase 1

Sponsor

Genascence Corporation

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05835895

The ClinicalTrials.gov registry entry for NCT05835895 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genascence Corporation, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05835895 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05835895 about?

NCT05835895 is a clinical study titled "Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis". The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.

What is the current status of trial NCT05835895?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2023-06-12. Estimated completion is 2029-05.

What conditions does trial NCT05835895 study?

This clinical trial studies the following conditions: Knee Osteoarthritis, Osteoarthritis, Knee, Osteo Arthritis Knee. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05835895?

The interventions under investigation include: Placebo (DRUG), GNSC-001 (GENETIC), transient immune-modulation (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05835895?

This trial is sponsored by Genascence Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05835895 being conducted?

This trial has 9 study locations across Alabama, California, Florida, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial