A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis

Xindu

Status and phase

Completed

Phase 2

Phase 1

Conditions

Osteoarthritis, Knee

Treatments

Biological: XSTEM-OA

Study type

Interventional

Funder types

Industry

Identifiers

NCT05344157

XIN-XSTEM-101

Details and patient eligibility

About

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-OA when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. The study is divided into two parts; a dose escalation (Part A) and an optional dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) may be further expanded in Part B.

Enrollment

24 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Major inclusion criteria:

Aged ≥40 and ≤75 years at Screening
Radiological evidence of predominantly medial osteoarthritis in the knee, uni- or bilateral, of KL grade II to III
Moderate to severe pain associated with osteoarthritis in the knee as measured by a VAS pain score of ≥35 and ≤90 mm

Major exclusion criteria:

Body mass index (BMI) of ≥35 at Screening
Ongoing signs or symptoms of systemic or local infection
Known knee infection in the study knee within 6 months of Screening
History of clinically relevant concomitant joint disease, clinically-relevant knee deformities, or any clinically significant medical history of the ligament, or realignment surgery or joint replacement surgery
Medical history of any autoimmune disease
History of surgery in the study knee that occured within 6 months of Screening
Treatment with immunosuppressive therapy (systemic or local) or any medication affecting the bone or cartilage metabolism within 6 months of Screening
Patients who are immunocompromised as caused by a disease