Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01088191




Registration number
NCT01088191
Ethics application status
Date submitted
11/03/2010
Date registered
17/03/2010
Date last updated
15/08/2018

Titles & IDs
Public title
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
Scientific title
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
Secondary ID [1] 0 0
MSB-CAR001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Injury 0 0
Osteoarthritis 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MSB-CAR001 Combined With Hyaluronan
Treatment: Drugs - Hyaluronan

Active Comparator: Hyaluronan Alone - Hyaluronan Alone

Experimental: MSB-CAR001 - Single Dose of MSB-CAR001 Combined With Hyaluronan


Other interventions: 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

Treatment: Drugs: Hyaluronan
Hyaluronan alone
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Emeritus Research - Malvern East
Recruitment postcode(s) [1] 0 0
3145 - Malvern East

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mesoblast, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01088191
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donna Skerrett, MD
Address 0 0
Mesoblast, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01088191