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

Primary Purpose

Anterior Cruciate Ligament Injury, Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

MSB-CAR001 Combined With Hyaluronan

Hyaluronan

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Acute Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Adult Stem Cells, Mesenchymal precursor cells

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emeritus Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hyaluronan Alone

MSB-CAR001

Arm Description

Hyaluronan Alone

Single Dose of MSB-CAR001 Combined With Hyaluronan

Outcomes

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).

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)

Full Information

NCT ID

NCT01088191

First Posted

March 11, 2010

Last Updated

August 13, 2018

Sponsor

Mesoblast, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01088191

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mesoblast, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Injury, Osteoarthritis

Keywords

Acute Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Adult Stem Cells, Mesenchymal precursor cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyaluronan Alone

Arm Type

Active Comparator

Arm Description

Hyaluronan Alone

Arm Title

MSB-CAR001

Arm Type

Experimental

Arm Description

Single Dose of MSB-CAR001 Combined With Hyaluronan

Intervention Type

Biological

Intervention Name(s)

MSB-CAR001 Combined With Hyaluronan

Other Intervention Name(s)

Anterior Cruciate Ligament Reconstruction, Adult Stem Cells, Knee Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hyaluronan

Other Intervention Name(s)

Active Control

Intervention Description

Hyaluronan alone

Primary Outcome Measure Information:

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donna Skerrett, MD

Organizational Affiliation

Mesoblast, Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Emeritus Research

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

28768528

Citation

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.

Results Reference

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

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