NCT03589287

Allogeneic Bone Marrow MSC Therapy for Knee Osteoarthritis

A Phase I/IIa Clinical Study of Treatment for Knee Osteoarthritis by Intra-articular Injection of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The Clinical trial is a phase I/IIa clinical study for treatment of knee osteoarthritis by intra-articular injection of bone marrow derived allogeneic mesenchymal stem cells. Primary endpoint of the study is safety of allogeneic BM-MSCs application on knee OA with single dose IA injection and the MTD. Secondary endpoint is the effect of allogeneic BM-MSCs transplantation including clinical and image observation since the MSCs have multi-lineage differentiation potential such as chondrocyte differentiation, anti-inflammation and immune-modulation.

Detailed description

Osteoarthritis of the knee (Knee Osteoarthritis, Knee OA) is a joint disease that primarily affects cartilage. Cartilage is the smooth tissue covering the ends of bones within the joint. In people who suffer from knee OA, articular cartilage top is broken down and worn away, resulting in the underlying bones to rub against each other. This friction can cause pain, joint swelling and decreased range of motion (ROM). Eventually, the joint may become deformed and bone spurs may form around the edges. With the advances in biotechnology, cell therapy in the application of cartilage reconstruction has gradually matured. The purpose of this study is to assess the safety and efficacy of single intra-articular (IA) injection of allogeneic bone marrow (BM) mesenchymal stem cells (MSCs) for knee OA. The same cell products used in this trial have been applied in a phase I/IIa clinical trial in Taiwan for the treatment of critical limb ischemia, and so far no treatment-related adverse effect has been observed. In the current trial, allogeneic bone marrow MSCs of up to 4 donors will be isolated. BM MSCs are expanded and applied for a phase I/IIa study in treating 15-24 recipient patients with knee OA. The treatment protocol consists of two stages: the first stage is a traditional 3+3 open dose-escalated study design with three cohorts of dosing groups: (1) 1 x 10\^7 cells, (2) 5 x 10\^7 cells and (3) 10 x 10\^7 cells. At the second stage, knee OA patients will be treated by the cell products of the maximum tolerance dose (MTD) as determined by the results of the first stage. All the study subjects will be followed up to 6 months (24 weeks) after the treatment for safety and preliminary efficacy evaluation, which the latter will include both clinical and imaging study assessments.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Chondrochymal®	Allogeneic Bone Marrow Derived Mesenchymal Stem Cells

Timeline

• Start date: 2018-05-02
• Primary completion: 2019-05-03
• Completion: 2020-04-30
• First posted: 2018-07-17
• Last updated: 2021-08-19

Locations

1 site across 1 country: Taiwan