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Knee OsteoarthritisPhase 1/2NCT03589287

Allogeneic Bone Marrow MSC Therapy for Knee Osteoarthritis

A Phase 1/2 study testing Chondrochymal® in people with Knee Osteoarthritis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Chondrochymal®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteTaiwan
Study dates
2 May 2018to 30 Apr 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 17Show fewer
  • 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)
  • Patients with severe unilateral (or bilateral) knee osteoarthritis who have decided to receive surgery (including total knee replacement) on the affected knee (or both knees if bilateral) after advised by their surgeon.
  • Having participated other clinical trials with medications (including cellular therapy) within the past 3 months prior to subject screening

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Chondrochymal®
Keywords
Intra-articular (IA), Allogeneic, MSC, OA
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chondrochymal®Biological

    Allogeneic Bone Marrow Derived Mesenchymal Stem Cells

Study groups in NCT03589287
Study groupRoleWhat they receive
Chondrochymal® 1 x 10^7 cellsExperimentalAt this stage, 3 patients with knee OA will be treated by the cell products of this dose.
Receives: Biological: Chondrochymal®
Chondrochymal® 5 x 10^7 cellsExperimentalAt this stage, 3 patients with knee OA will be treated by the cell products of this dose.
Receives: Biological: Chondrochymal®
Chondrochymal® 10 x 10^7 cellsExperimentalAt this stage, 3 patients with knee OA will be treated by the cell products of this dose.
Receives: Biological: Chondrochymal®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events as measure of safety and tolerability

    treatment-related adverse events assessed by CTCAE v4.0

    Measured: 24 weeks

Secondary outcomes (6)

  1. Efficacy - Radiographic evidence

    Change in cartilage thickness of the knee using MRI and X-ray

    Measured: 24 weeks

  2. Efficacy - WOMAC assessment

    Change in joint function from baseline WOMAC assessment

    Measured: 24 weeks

  3. Efficacy - Visual Analogue Scale(VAS) assessment

    The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "worst imaginable pain" (score of 10).

    Measured: 24 weeks

  4. Efficacy - Lequesne Index assessment

    Change in arthritis pain scores on the Lequesne Index

    Measured: 24 weeks

  5. Efficacy - Keen Society Score(KSS) assessment

    The knee society score is divided into four parts: it consists of the ''Symptoms''(25 points), the ''Patient satisfaction''(40 points), the ''Patient expectation''(15 points) and the ''Functional activities''(100 points). Each part will be evaluated separately.

    Measured: 24 weeks

  6. Efficacy - QOL assessment

    Change in scores on the QOL

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2018
  2. Study start2 May 2018
  3. Primary completion3 May 2019
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589287
Sponsor's protocol ID
2016-11-006C
Status last verified
Aug 2021
First submitted
4 Jun 2018
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chondrochymal® in people with Knee Osteoarthritis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events as measure of safety and tolerability (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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