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Completed

NCT Number: NCT05344157

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Genesis Research Services, Broadmeadow, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety and tolerability: Adverse events (AEs)

    Time frame: 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)

  2. Safety and tolerability: 12-lead electrocardiogram (ECG)

    Time frame: From start of study until 18 months after injection

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

  3. Safety and tolerability: Laboratory examinations

    Time frame: 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.

  4. Safety and tolerability: Physical examinations

    Time frame: From start of study until 18 months after injection

    Changes in physical examination compared to baseline.

  5. Safety and tolerability: Vital signs

    Time frame: 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.

Secondary outcomes

  1. Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline

    Time frame: From start of study until 18 months after injection

  2. Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline

    Time frame: From start of study until 18 months after injection

  3. Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline

    Time frame: From start of study until 18 months after injection

  4. Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline

    Time frame: From start of study until 18 months after injection

  5. Preliminary efficacy: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition

    Time frame: From start of study until 18 months after injection

  6. Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS)

    Time frame: From start of study until 18 months after injection

  7. Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis

    Time frame: From start of study until 18 months after injection

  8. Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline

    Time frame: From start of study until 18 months after injection

Other outcomes

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

    Time frame: 24 months after injection

  2. Exploratory outcome: Change in KOOS compared to baseline

    Time frame: 24 months after injection

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

    Time frame: 24 months after injection

  4. Exploratory outcome: Change in 40 m fast paced walk test compared to baseline

    Time frame: 24 months after injection

  5. Exploratory outcome: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition

    Time frame: 24 months after injection

  6. Exploratory outcome: Change in whole knee health compared to baseline, based on MRI

    Time frame: 24 months after injection

  7. Exploratory outcome: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis

    Time frame: 24 months after injection

  8. Exploratory outcome: Change in joint space narrowing based on x-ray compared to baseline

    Time frame: 24 months after injection

Sponsors and collaborators

Lead sponsor

Xindu Pty Ltd

Industry

Collaborators

  • Xintela AB

Registry information

Official study title

A First-in-Human Open-Label Phase 1/2a Study to Evaluate Safety, Tolerability and Efficacy of a Single Intra-Articular Injection of Allogeneic Mesenchymal Stem Cells Selected for Integrin α10β1 (XSTEM-OA) in Adult Patients With Symptomatic Knee Osteoarthritis

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2022
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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