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Osteoarthritis of KneePhase 1/2NCT02351011

Human Autologous MSCs for the Treatment of Mid to Late Stage Knee OA

A Phase 1/2 study testing 1 x 10^6 MSCs, 10 x 10^6 MSCs and 50 x 10^6 MSCs in people with Osteoarthritis of Knee, run by Jas Chahal at 1 site in Canada.

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

Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Osteoarthritis of Knee
What is being tested?
1 x 10^6 MSCs, 10 x 10^6 MSCs and 50 x 10^6 MSCs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
Feb 2015to Dec 2018
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between 40-65 years of age with symptomatic moderate to severe (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee
  • Failed conservative management including physical therapy, bracing and/or oral anti-inflammatories for a minimum of six months
  • No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
  • No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
  • Adequate bone marrow, liver, and renal functions
  • Body weight >40 kg
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  • Body Mass Index <30
  • Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
  • Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection.
  • Fluid > 1 cm within the lateral recess of the suprapatellar pouch at the level of the superior pole of the patella with the knee extended.

Who cannot join

  • Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
  • Patients with varus or valgus malalignment >5 degrees as measured by 4 foot standing antero-posterior radiographs
  • Patients with a history of a previous subtotal medial or lateral meniscectomy
  • Patients with a history of septic arthritis in the affected joint
  • Patients with a history of a prior intra-articular knee fracture
  • Severe bleeding diathesis
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  • Contraindication to bone marrow aspiration and/or biopsy
  • Active infection
  • Bone marrow failure
  • Cytopenia
  • Patients who have previously received radiotherapy to the pelvis
  • Patients who have been on chemotherapy from within a year of the date of informed
  • Patients with positive serological test for (HIV, HTLV1\&2, Hep A, B, C, syphilis)
  • Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)
  • Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Human Autologous Mesenchymal Stromal Cells for the Treatment of Mid to Late Stage Knee Osteoarthritis

Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA.

Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. This will be done by starting at a low dose of MSCs and moving on to the next higher dose level provided there are no safety concerns. Researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.

Read the detailed description

The trial is a non-randomized, open-label, dose escalation phase I/II clinical trial. A total of 12 participants will be enrolled - patients will be treated in cohorts of 3 to determine the safety and preliminary efficacy of autologous, ex-vivo expanded bone-marrow derived MSC injected into the knee joint in patients with moderate to advanced knee osteoarthritis.

A minimum of three evaluable patients will be entered at each dose level until the maximum tolerated dose (MTD) is reached. Toxicity will be evaluated and graded according to the Common Terminology Criteria (CTC) for Adverse Events, as Grade 3-4. If a patient is discontinued due to a grade 3 or 4 adverse event (i.e. dose-limiting toxicity, DLT), an additional patient will be enrolled at the same dose level to ensure that a minimum of 3 patients are evaluated. If 0/3 patients experience dose-limiting (DLT) at a given dose level, then the dose will be escalated for next cohort of 3 patients. If 1/3 patients experience DLT at a given dose level, then an additional 3 patients will be treated at that dose level. If no other patient experiences a DLT, dose escalation will continue. If DLT occurs in 2/3 or 2/6 patients, dose escalation will stop and the prior dose level will be declared the MTD for the MSC cell infusions in this study.

Being tested
1 x 10^6 MSCs, 10 x 10^6 MSCs, 50 x 10^6 MSCs
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • 1 x 10^6 MSCsBiological

    Also called Mesenchymal Stromal Cells (MSCs)

    Autologous, bone-marrow derived MSCs

  • 10 x 10^6 MSCsBiological

    Also called Mesenchymal Stromal Cells (MSCs)

    Autologous, bone-marrow derived MSCs

  • 50 x 10^6 MSCsBiological

    Also called Mesenchymal Stromal Cells (MSCs)

    Autologous, bone-marrow derived MSCs

Study groups in NCT02351011
Study groupRoleWhat they receive
Cohort 1Experimental1 x 10^6 MSCs
Receives: Biological: 1 x 10^6 MSCs
Cohort 2Experimental10 x 10^6 MSCs
Receives: Biological: 10 x 10^6 MSCs
Cohort 3Experimental50 x 10^6 MSCs
Receives: Biological: 50 x 10^6 MSCs

What is being measured

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

  1. Safety as determined by the occurrence of local and systemic adverse events and/or serious adverse events.

    Safety as determined by the occurrence of local and systemic adverse events and/or serious adverse events.

    Measured: 1 to 5 years

Secondary outcomes (10)

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Knee-joint specific function

    Measured: 1 year

  2. Marx Activity Scale (Patient-reported activity)

    Patient-reported activity

    Measured: 1 year

  3. Short-Form 36 (Health-related quality of life)

    Health-related quality of life

    Measured: 1 year

  4. Whole Organ MRI Score (WORMS), Gadolinium-enhanced MRI, T2 Mapping (To assess joint structure, inflammation, and cartilage status over time)

    To assess joint structure, inflammation, and cartilage status over time

    Measured: 1 year

  5. Cartilage oligomeric matrix protein (COMP)

    Serum marker of cartilage metabolism

    Measured: 1 year

  6. Hyaluronic acid (HA)

    Serum pro-inflammatory marker

    Measured: 1 year

  7. C-terminal telopeptide of type II collagen (CTXII)

    Urine marker of cartilage metabolism

    Measured: 1 year

  8. Types I and II collagen cleavage (C1,2C)

    Urine marker of cartilage metabolism

    Measured: 1 year

  9. Type II collagen cleavage (C2C)

    Urine marker of cartilage metabolism

    Measured: 1 year

  10. IL-6/TNFα/IL-15

    Synovial fluid pro-inflammatory markers

    Measured: 1 year

Timeline

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

  1. First posted30 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

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
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02351011
Sponsor's protocol ID
MSC-001
Status last verified
Sep 2019
First submitted
20 Jan 2015
Last updated
27 Sep 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 1 x 10^6 MSCs, 10 x 10^6 MSCs and 50 x 10^6 MSCs in people with Osteoarthritis of Knee, run by Jas Chahal at 1 site in Canada.

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 10 inclusion and 15 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 27 Sep 2019. 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 Canada. 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?

Safety as determined by the occurrence of local and systemic adverse events and/or serious adverse events. (time frame: 1 to 5 years). 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 NCT02351011.

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 27 Sep 2019.

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