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

Phase 1

Active, not recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: XSTEM-OA

• Registration Number: NCT05344157
• Lead Sponsor: Xindu Pty Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-06-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XSTEM-OA	XSTEM-OA	Single intra-articular injection of XSTEM-OA

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: 12-lead electrocardiogram (ECG)	From start of study until 18 months after injection	Change in 12-lead electrocardiograms (ECGs) compared to baseline.
Safety and tolerability: Laboratory examinations	From start of study until 18 months after injection	Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.
Safety and tolerability: Physical examinations	From start of study until 18 months after injection	Changes in physical examination compared to baseline.
Safety and tolerability: Vital signs	From start of study until 18 months after injection	Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature.
Safety and tolerability: Adverse events (AEs)	From start of study until 24 months after injection	Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)

Secondary Outcome Measures

Name	Time	Method
Preliminary efficacy: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition	From start of study until 18 months after injection
Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline	From start of study until 18 months after injection
Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS)	From start of study until 18 months after injection
Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline	From start of study until 18 months after injection
Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis	From start of study until 18 months after injection
Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline	From start of study until 18 months after injection
Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline	From start of study until 18 months after injection
Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline	From start of study until 18 months after injection

Trial Locations

Locations (2)

Genesis Research Services; 🇦🇺 Broadmeadow, New South Wales, Australia

Emeritus Research; 🇦🇺 Camberwell, Victoria, Australia