Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction

August 13, 2018 updated by: Mesoblast, Ltd.

Phase 2 Study to Assess Safety & Tolerability of a Single Injection Into the Knee Joint of Two Different Doses of MSB-CAR001 Combined With Hyaluronan Compared to Hyaluronan Alone in Patients Who Have Undergone an ACL Reconstruction

The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single center, randomized, double blind, controlled Phase 1b/2a study designed to evaluate the safety and tolerability of a single injection into the knee joint of two different doses of MPCs combined with Hyaluronan compared to Hyaluronan alone in patients who have recently undergone an Anterior Cruciate Ligament Reconstruction.

All subjects in this study have undergone unilateral ACL reconstruction surgery within six months of injury. MSB-CAR001 plus Hyaluronan at one of two doses or Hyaluronan alone will be injected into the knee joint.

After the screening and injection visits, each subject will be evaluated clinically within 3 days and 28 days after surgery, and at 2, 3, 6, 9, 12, 18, and 24 months after surgery. The radiographical exams will be performed at 6, 12, 18, and 24 months after surgery.

Subjects will be evaluated at 24 months after surgery for safety.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Malvern East, Victoria, Australia, 3145
        • Emeritus Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females at least 18 years of age, but not older than 40
  2. ACL injury requiring reconstruction
  3. Have undergone unilateral ACL reconstruction surgery within six months of injury;
  4. Willing and able to undertake a standardized rehabilitation protocol
  5. ACL graft used is autograft
  6. Willingness to participate in follow-up for 24 months from the time of initial treatment
  7. Ability to understand and willingness to sign consent form

Exclusion Criteria:

  1. Women who are pregnant or breast feeding or planning to become pregnant during the study
  2. Previous allergic reaction to Hyaluronan
  3. Systemic or local infection at the screen visit or at the time of the study injection
  4. History of any autoimmune disease, such as, systemic lupus erythematosus, Addison's disease, Crohn's disease, or rheumatoid arthritis
  5. Treatment with immunosuppression therapy within 6 months prior to screen (visit 1)
  6. Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
  7. Treatment and /or uncompleted follow-up treatment of any investigational therapy within 6 months before the procedure and /or intent to participate in any other investigational drug or cell therapy study during the 24 month follow-up period of this study;
  8. Recipient of prior allogeneic stem cell/progenitor cell therapy
  9. Undergoing a simultaneous procedure to the opposite knee
  10. 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens;
  11. Known sensitivities to bovine (cow), murine (mouse), chicken products and/or dimethylsulfoxide (DMSO). Previous allergic reaction to Hyaluronan;
  12. History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
  13. History of prior surgery to the study knee joint
  14. History of malignancy (excluding basal cell carcinoma that has been successfully excised)
  15. Chondral lesions noted at time of surgical reconstruction greater than Grade 1a on any surfaces

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyaluronan Alone
Biological: MSB-CAR001 Combined With Hyaluronan

Knee Injection of Biological: MSB-CAR001 Combined With Hyaluronan

Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan

Other Names:
  • Anterior Cruciate Ligament Reconstruction
  • Adult Stem Cells
  • Knee Injection
Drug: Hyaluronan
Hyaluronan alone
Other Names:
  • Active Control
Experimental: MSB-CAR001
Single Dose of MSB-CAR001 Combined With Hyaluronan
Biological: MSB-CAR001 Combined With Hyaluronan

Knee Injection of Biological: MSB-CAR001 Combined With Hyaluronan

Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan

Other Names:
  • Anterior Cruciate Ligament Reconstruction
  • Adult Stem Cells
  • Knee Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the overall safety of MSB-CAR001 plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the overall efficacy with MSB-CAR001 plus Hyaluronan compared to Hyaluronan alone using MRI scans and x-ray of the involved knee joint and access the change in outcomes (KOOS, SF-36) and pain (VAS)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoblast, Ltd.

Investigators

  • Study Director: Donna Skerrett, MD, Mesoblast, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 17, 2010

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSB-CAR001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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