- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088191
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Victoria
-
Malvern East, Victoria, Australia, 3145
- Emeritus Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females at least 18 years of age, but not older than 40
- ACL injury requiring reconstruction
- Have undergone unilateral ACL reconstruction surgery within six months of injury;
- Willing and able to undertake a standardized rehabilitation protocol
- ACL graft used is autograft
- Willingness to participate in follow-up for 24 months from the time of initial treatment
- Ability to understand and willingness to sign consent form
Exclusion Criteria:
- Women who are pregnant or breast feeding or planning to become pregnant during the study
- Previous allergic reaction to Hyaluronan
- Systemic or local infection at the screen visit or at the time of the study injection
- History of any autoimmune disease, such as, systemic lupus erythematosus, Addison's disease, Crohn's disease, or rheumatoid arthritis
- Treatment with immunosuppression therapy within 6 months prior to screen (visit 1)
- Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
- 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;
- Recipient of prior allogeneic stem cell/progenitor cell therapy
- Undergoing a simultaneous procedure to the opposite knee
- 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens;
- Known sensitivities to bovine (cow), murine (mouse), chicken products and/or dimethylsulfoxide (DMSO). Previous allergic reaction to Hyaluronan;
- History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
- History of prior surgery to the study knee joint
- History of malignancy (excluding basal cell carcinoma that has been successfully excised)
- Chondral lesions noted at time of surgical reconstruction greater than Grade 1a on any surfaces
Study Plan
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
|
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:
Hyaluronan alone
Other Names:
|
Experimental: MSB-CAR001
Single Dose of 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:
|
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
Sponsor
Investigators
- Study Director: Donna Skerrett, MD, Mesoblast, Ltd.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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