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
1 other identifier
interventional
17
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedAugust 15, 2018
August 1, 2018
4.7 years
March 11, 2010
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
2 years
Secondary Outcomes (1)
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)
2 years
Study Arms (2)
Hyaluronan Alone
ACTIVE COMPARATORHyaluronan Alone
MSB-CAR001
EXPERIMENTALSingle Dose of MSB-CAR001 Combined With Hyaluronan
Interventions
Knee Injection of Biological: MSB-CAR001 Combined With Hyaluronan Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- % 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Ltd.lead
Study Sites (1)
Emeritus Research
Malvern East, Victoria, 3145, Australia
Related Publications (1)
Wang Y, Shimmin A, Ghosh P, Marks P, Linklater J, Connell D, Hall S, Skerrett D, Itescu S, Cicuttini FM. Safety, tolerability, clinical, and joint structural outcomes of a single intra-articular injection of allogeneic mesenchymal precursor cells in patients following anterior cruciate ligament reconstruction: a controlled double-blind randomised trial. Arthritis Res Ther. 2017 Aug 2;19(1):180. doi: 10.1186/s13075-017-1391-0.
PMID: 28768528DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Donna Skerrett, MD
Mesoblast, Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 17, 2010
Study Start
March 1, 2009
Primary Completion
November 1, 2013
Study Completion
October 1, 2014
Last Updated
August 15, 2018
Record last verified: 2018-08