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

Xindu Pty Ltd24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

XSTEM-OABIOLOGICAL

XSTEM-OA is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of osteoarthritis.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Genesis Research Services

Broadmeadow, New South Wales, Australia

Emeritus Research

Camberwell, Victoria, Australia

Outcomes

Primary Outcomes

Safety and tolerability: Adverse events (AEs)

Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)

Time frame: From start of study until 24 months after injection

Safety and tolerability: 12-lead electrocardiogram (ECG)

Change in 12-lead electrocardiograms (ECGs) compared to baseline.