Allogeneic Bone Marrow MSC Therapy for Knee Osteoarthritis

NCT03589287 | Completed Phase 1 DMC

• 1 other identifier: 2016-11-006C
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Intra-articular (IA), Allogeneic, MSC, OA

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as measure of safety and tolerability

  treatment-related adverse events assessed by CTCAE v4.0

  24 weeks

Secondary Outcomes (6)

• Efficacy - Radiographic evidence

  24 weeks

• Efficacy - WOMAC assessment

  24 weeks

• Efficacy - Visual Analogue Scale(VAS) assessment

  24 weeks

• Efficacy - Lequesne Index assessment

  24 weeks

• Efficacy - Keen Society Score(KSS) assessment

  24 weeks

Study Arms (3)

Chondrochymal® 1 x 10^7 cells

EXPERIMENTAL

At this stage, 3 patients with knee OA will be treated by the cell products of this dose.

Biological: Chondrochymal®

Chondrochymal® 5 x 10^7 cells

EXPERIMENTAL

At this stage, 3 patients with knee OA will be treated by the cell products of this dose.

Biological: Chondrochymal®

Chondrochymal® 10 x 10^7 cells

EXPERIMENTAL

At this stage, 3 patients with knee OA will be treated by the cell products of this dose.

Biological: Chondrochymal®

Interventions

Chondrochymal® BIOLOGICAL

Allogeneic Bone Marrow Derived Mesenchymal Stem Cells

Chondrochymal® 1 x 10^7 cells; Chondrochymal® 10 x 10^7 cells; Chondrochymal® 5 x 10^7 cells

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 40 years old, completing the informed consent process for participating the clinical trial
• Patients diagnosed with unilateral/bilateral knee osteoarthritis of grade II, III and IV (Kellgren and Lawrence scale) as assessed by doctors, who are not suitable for, or not willing to undergo knee surgery (including total knee replacement)
• Pain of the knee as assessed by visual analogue scale (VAS) to be 4 or higher (VAS ≥ 4)
• Body mass index (BMI) between 20 and 35 kg/m2
• Neither local/systemic bacteremia nor acute infection around the knee joint

You may not qualify if:

• Physiologically or psychologically inappropriate for participating the trial as evaluated by the investigators
• Patients with congenital or acquired bone hypoplasia (Varus more than 10o or Valgus more than 20o)
• BMI less than 20 or more than 35 (Class II obesity)
• Female who is pregnant or breastfeeding, or in childbearing age; male or female subjects who are not able to use appropriate contraception methods during the trial
• Patients with muscular or neurological diseases causing deformity of the targeted knee joint(s), which might interfere with the evaluation of trial.
• Patients with malignant tumors, or benign tumors that may interfere with the trial treatment or subsequent evaluation.
• Immunocompromised or patients suffering from immune diseases under long-term immuno-suppressive medication such as steroids, however, topical steroid is not included
• Patients with coagulation or hematological disorders not suitable for intra-articular (IA) injection
• Known or possible allergy to components in the product under trial
• Patients had any IA injection or surgery of the targeted knee within the last 3 months
• Patients with crippled lower limbs rated ACR functional class IV (Largely or Wholly Incapacitated) or cannot walk without one/two arms-operated walking assisting device (defined by CNS15390)
• Spontaneous knee osteonecrosis
• Previous surgery of the knee that may cause metal imaging artifacts on imaging study
• Patients have claustrophobia and/or cannot take magnetic resonance imaging (MRI) test
• Any metal devices placed in the body such as pacemaker, artificial heart valve, or hemostatic clamps/clips for intracranial aneurysm posing risk under magnetic field (of MRI)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ming-Chau Chang, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The treatment protocol consists of two stages: the first stage is a traditional 3+3 dose-escalation open study design with three cohorts. At the second stage, a total of 6 patients with knee OA will be treated by the cell products of the maximum tolerance dose (MTD) as determined by the results of the first stage.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 17, 2018
• Study Start: May 2, 2018
• Primary Completion: May 3, 2019
• Study Completion: April 30, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

TW (1)