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

NCT ID: NCT05344157

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2025-06-18

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XSTEM-OA

Single intra-articular injection of XSTEM-OA

Group Type: EXPERIMENTAL

XSTEM-OA

Intervention Type: BIOLOGICAL

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

Interventions

XSTEM-OA

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xintela AB

INDUSTRY

Sponsor Role: collaborator

Xindu Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Norlén, MD, PhD

Role: STUDY_DIRECTOR

Xintela AB

Stephen Hall, Dr

Role: PRINCIPAL_INVESTIGATOR

Emeritus Research

Locations

Genesis Research Services

Broadmeadow, New South Wales, Australia

Emeritus Research

Camberwell, Victoria, Australia

Countries

Australia

Other Identifiers

XIN-XSTEM-101

Identifier Type: -

Identifier Source: org_study_id