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

Clinical trial · Genascence Corporation

- Archive id: nct:NCT07831577
- Published: 2026-09-21
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07831577
- Source URL: https://clinicaltrials.gov/study/NCT07831577
- Provenance: clinicaltrials

## Abstract

The goal of this clinical trial is to learn if GNSC-001 works to treat knee osteoarthritis in adults. It will also learn about the safety of GNSC-001. The main questions it aims to answer are: 1. Does GNSC-001 lower daily knee joint pain and improve function in participants? 2. What medical problems do participants have when taking GNSC-001? Researchers will compare GNSC-001 to a placebo (a look-alike substance that contains no drug) to see if GNSC-001 works to treat knee osteoarthritis. Participants will: 1. Receive a single injection of immune-modulation, and GNSC-001 or a placebo, in their knee 2. Take an oral immune-modulating pill every day for the first 22 days 3. Visit the clinic at least 9 times over 2 years for checkups and tests 4. Keep a diary of their symptoms and the number of times they use a rescue medication

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- acronym: RAPHAEL
- status: NOT_YET_RECRUITING
- phase: PHASE2, PHASE3
- study type: INTERVENTIONAL
- enrollment: 240
- sponsor: Genascence Corporation
- conditions: Knee Arthritis Osteoarthritis; Knee Arthritis, Osteoarthritis; Knee Arthritis; Knee Arthritis Disease; Osteo Arthritis of the Knee; Osteoarthritic Knee Pain; Osteoarthritis (OA) of the Knee; Osteo Arthritis Knee; Pain (Knee)
- interventions: DRUG: Gene Therapy GNSC-001; DRUG: Placebo
- start date: 2027-07-01
- start date type: ESTIMATED
- primary completion date: 2029-10-01
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Gene & Cell Therapy](https://space-kitty.com/topics/gene-cell-therapy)

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