Anterior Cruciate Ligament InjuryPhase 1/2NCT01088191
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
A Phase 1/2 study testing MSB-CAR001 Combined With Hyaluronan and Hyaluronan in people with Anterior Cruciate Ligament Injury and Osteoarthritis, run by Mesoblast, Ltd. at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Osteoarthritis
- What is being tested?
- MSB-CAR001 Combined With Hyaluronan and Hyaluronan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2009to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury, Osteoarthritis
- Being tested
- MSB-CAR001 Combined With Hyaluronan, Hyaluronan
- Keywords
- Acute Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Adult Stem Cells, Mesenchymal precursor cells
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSB-CAR001 Combined With HyaluronanBiological
Also called Anterior Cruciate Ligament Reconstruction, Adult Stem Cells, Knee Injection
Knee Injection of Biological: MSB-CAR001 Combined With Hyaluronan
Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan
HyaluronanDrug
Also called Active Control
Hyaluronan alone
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronan Alone | Active comparator | Hyaluronan Alone Receives: Biological: MSB-CAR001 Combined With Hyaluronan; Drug: Hyaluronan |
| MSB-CAR001 | Experimental | Single Dose of MSB-CAR001 Combined With Hyaluronan Receives: Biological: MSB-CAR001 Combined With Hyaluronan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionNov 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donna Skerrett, MD, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088191
- Sponsor's protocol ID
- MSB-CAR001
- Status last verified
- Aug 2018
- First submitted
- 11 Mar 2010
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28768528
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01088191
- Acronym / sponsor ID
- MSB-CAR001
- Conditions
- Anterior Cruciate Ligament Injury, Osteoarthritis
- Keywords
- Acute Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Adult Stem Cells, Mesenchymal precursor cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronan Alone | Active comparator | Biological: MSB-CAR001 Combined With Hyaluronan, Drug: HyaluronanHyaluronan Alone |
| MSB-CAR001 | Experimental | Biological: MSB-CAR001 Combined With HyaluronanSingle Dose of MSB-CAR001 Combined With Hyaluronan |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSB-CAR001 Combined With HyaluronanAlso: Anterior Cruciate Ligament Reconstruction, Adult Stem Cells, Knee InjectionKnee Injection of Biological: MSB-CAR001 Combined With Hyaluronan Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan | Biological | Hyaluronan Alone, MSB-CAR001 |
| HyaluronanAlso: Active ControlHyaluronan alone | Drug | Hyaluronan Alone |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 28768528Wang 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.
- Sponsor WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Skerrett, MD study director
Mesoblast, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSB-CAR001 Combined With Hyaluronan and Hyaluronan in people with Anterior Cruciate Ligament Injury and Osteoarthritis, run by Mesoblast, Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01088191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.