Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients With Knee Osteoarthritis in Grade III/IV by K/L

Anterogen

Status and phase: Active, not recruiting; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Biological: ANT-301

Study type: Interventional

Funder types: Industry

Identifiers

NCT06539429

ANT-301-102

Details and patient eligibility

About

This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K&L Grade III/IV.

Full description

Study Design: open-label, single-center, dose-escalation study

Enrollment: 6 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
2. Patients aged 19 to 70 years old.
3. Patients diagnosed with K&L grade III/IV knee osteoarthritis
4. Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale

Exclusion criteria

1. Patients with joint diseases other than osteoarthritis
2. Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
3. Patients who received intra-articular injections within 6 months prior to the screening
4. Patients who have received systemic steroid therapy within 3 months prior to the screening
5. Patients who have received immunosuppressive agents within 3 months prior to the screening
6. Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening
7. Patients who are unwilling to use contraception during the clinical trial period

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

ANT-301

Experimental group

Description:

Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel

Treatment:

Biological: ANT-301