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

NCT05344157 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-26

No results posted yet for this study

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

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Xintela AB

    collaborator INDUSTRY

  • Xindu Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Per Norlén, MD, PhD · Xintela AB

  • Stephen Hall, Dr · Emeritus Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2025-06-18
Completion
2025-06-18

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05344157 on ClinicalTrials.gov