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

Brief summary

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

Source: 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. Not a U.S. Government endorsement.

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