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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01088191
First received: March 11, 2010
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Anterior Cruciate Ligament Injury
Osteoarthritis
 Biological: MSB-CAR001 Combined With Hyaluronan
Drug: Hyaluronan
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hyaluronan Alone
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088191

Locations
Australia, Victoria
Emeritus Research
Malvern East, Victoria, Australia, 3145
Sponsors and Collaborators
Mesoblast, Ltd.
Investigators
Study Director: Donna Skerrett, MD Mesoblast, Ltd.
  More Information

Additional Information:
Sponsor Website  This link exits the ClinicalTrials.gov site
NIH Stem Cell Information Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01088191     History of Changes
Other Study ID Numbers: MSB-CAR001
Study First Received: March 11, 2010
Last Updated: June 12, 2013
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Mesoblast, Ltd.:
Acute Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Reconstruction
Adult Stem Cells
Mesenchymal precursor cells

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013