NCT05081921

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

A Randomized, Double Blind, Two Arms, Controlled Phase I/II Safety and Efficacy Study on MesoCellA-Ortho Tissue Engineered Product Intraarticularly Administrated in Adult Patients With Osteoarthrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To evaluate safety, tolerability and clinical efficacy of a MesoCellA-Ortho product, the active substance of MesoCellA-Ortho consisting of 20 mln in vitro expanded autologous human adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) will be intraarticularly administrated in adult patients with osteoarthritis and additionally burdened with other civilisation diseases such as type 2 diabetes and/ or obesity. Hyaluronic acid (HA) will be used as a Control. The safety and clinical outcome of the treatment will be evaluated during 6 months of followup, considering patient's subjective pain level and evaluation of the improvement of knee joint function.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-05
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2021-10-18
• Last updated: 2024-03-21

Locations

1 site across 1 country: Poland