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Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases

NCT05081921 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2024-03-21

No results posted yet for this study

Summary

The aim of the study is to evaluate safety, tolerability and clinical efficacy of a newly developed MesoCellA-Ortho tissue-engineered advanced therapy medicinal product in adult patients suffering with osteoarthritis and additionally burdened with other civilisation diseases such as type 2 diabetes and/ or obesity.

The active substance of MesoCellA-Ortho consists of in vitro expanded autologous human adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) resuspended in carrier solution for intraarticular injections for individual patents.

Conditions

  • Osteoarthritis of Knee

Interventions

DRUG

MesoCellA-Ortho administration

Single dose of MesoCellA-Ortho product consisting of 20 mln of autologous adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) will be administrated intraarticularly in patients enrolled in "MesoCellA-Ortho- treated" groups.

DRUG

HA administration

Single dose of hyaluronic acid (HA) will be administrated intraarticularly as an active control in patients enrolled in "Control Patients" groups.

Sponsors & Collaborators

  • National Center for Research and Development, Poland

    collaborator OTHER

  • KCRI

    collaborator OTHER

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Krzysztof Ficek, Prof., MD, PhD, DSc · Galen Ortopedia Sp. z o. o

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2024-02-20
Completion
2024-02-20

Countries

  • Poland

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 NCT05081921 on ClinicalTrials.gov