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

Primary Purpose

Osteoarthritis, Knee

Status

Recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

XSTEM-OA

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Genesis Research Services
Emeritus ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XSTEM-OA

Arm Description

Single intra-articular injection of XSTEM-OA

Outcomes

Primary Outcome Measures

Safety and tolerability: Adverse events (AEs)

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

Safety and tolerability: 12-lead electrocardiogram (ECG)

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

Safety and tolerability: Laboratory examinations

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

Safety and tolerability: Physical examinations

Changes in physical examination compared to baseline.

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.

Secondary Outcome Measures

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

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

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

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

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

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

Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovial thickness and synovial blood flow

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

Full Information

NCT ID

NCT05344157

First Posted

April 4, 2022

Last Updated

December 2, 2022

Sponsor

Xindu Pty Ltd

Collaborators

Xintela AB

1. Study Identification

Unique Protocol Identification Number

NCT05344157

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 22, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xindu Pty Ltd

Collaborators

Xintela AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 a dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) will be further expanded in Part B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XSTEM-OA

Arm Type

Experimental

Arm Description

Single intra-articular injection of XSTEM-OA

Intervention Type

Biological

Intervention Name(s)

XSTEM-OA

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety and tolerability: Adverse events (AEs)

Description

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

Time Frame