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

NCT05344157 | Completed Phase 1

• 1 other identifier: XIN-XSTEM-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability: Adverse events (AEs)

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

  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.

  From start of study until 18 months after injection

• Safety and tolerability: Laboratory examinations

  Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.

  From start of study until 18 months after injection

• Safety and tolerability: Physical examinations

  Changes in physical examination compared to baseline.

  From start of study until 18 months after injection

• Safety and tolerability: Vital signs

  Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature.

  From start of study until 18 months after injection

Secondary Outcomes (8)

• Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain 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

• 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 40 m fast paced walk test compared to baseline

  From start of study until 18 months after injection

• 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

Other Outcomes (8)

• Exploratory outcome: Change in Visual Analogue Scale (VAS) for pain compared to baseline

  24 months after injection

• Exploratory outcome: Change in KOOS compared to baseline

  24 months after injection

• Exploratory outcome: Change in EQ-5D-5L compared to baseline

  24 months after injection

Study Arms (1)

XSTEM-OA

EXPERIMENTAL

Single intra-articular injection of XSTEM-OA

Biological: XSTEM-OA

Interventions

XSTEM-OA BIOLOGICAL

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

XSTEM-OA

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xindu Pty Ltd: lead
• Xintela AB: collaborator

Study Sites (2)

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Per Norlén, MD, PhD

  Xintela AB

  STUDY DIRECTOR

• Stephen Hall, Dr

  Emeritus Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 25, 2022
• Study Start: June 22, 2022
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)