Recovery Following Partial Medial MeniscectomyPhase 1/2NCT00702741
Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy
A Phase 1/2 study testing Chondrogen in people with Recovery Following Partial Medial Meniscectomy, run by Mesoblast International Sàrl at 4 sites in United States.
Trial summary
The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Recovery Following Partial Medial Meniscectomy
- What is being tested?
- Chondrogen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2008to Sep 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject must have received an injection in Protocol No. 550
- Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
- Subject must provide written informed consent for entry into the extension study
- Subject must provide authorization for use and disclosure of protected health information for entry into the extension study
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
TRIA Orthopaedic Center
Bloomington, Minnesota
OrthoIndy
Indianapolis, Indiana
University of Southern California Keck School of Medicine
Los Angeles, California
Unlimited Research
San Antonio, Texas
About this study
Official title: A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years
The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).
Read the detailed description
The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.
- Being tested
- Chondrogen, Placebo
- Keywords
- Knee, Meniscus, Meniscectomy, Mesenchymal Stem Cells, MSCs, Adult Human Stem Cells, Osiris, Chondrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChondrogenDrug
Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
ChondrogenDrug
Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
PlaceboDrug
Intra-articular injection of Hyaluronan
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Chondrogen (low dose) Receives: Drug: Chondrogen |
| B | Experimental | Chondrogen (high dose) Receives: Drug: Chondrogen |
| C | Placebo comparator | Hyaluronan Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of treatment adverse event rates
Measured: Through 3 years
Secondary outcomes (2)
Concomitant Medications
Measured: Through 3 years
Visual Analog Scale
Measured: Through 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery Following Partial Medial MeniscectomyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702741
- Sponsor's protocol ID
- 551
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2008
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years
- ClinicalTrials.gov ID
- NCT00702741
- Acronym / sponsor ID
- 551
- Keywords
- Knee, Meniscus, Meniscectomy, Mesenchymal Stem Cells, MSCs, Adult Human Stem Cells, Osiris, Chondrogen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Mesoblast International SàrlIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jun 2008 (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 objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).
Detailed description
The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ChondrogenChondrogen (low dose) |
| B | Experimental | Drug: ChondrogenChondrogen (high dose) |
| C | Placebo comparator | Drug: PlaceboHyaluronan |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject must have received an injection in Protocol No. 550
- Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
- Subject must provide written informed consent for entry into the extension study
- Subject must provide authorization for use and disclosure of protected health information for entry into the extension study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ChondrogenIntra-articular injection of ex vivo cultured adult human mesenchymal stem cells | Drug | A |
| ChondrogenIntra-articular injection of ex vivo cultured adult human mesenchymal stem cells | Drug | B |
| PlaceboIntra-articular injection of Hyaluronan | Drug | C |
Primary outcome
Comparison of treatment adverse event rates
Time frame: Through 3 years
2 secondary outcomes
Concomitant Medications
Time frame: Through 3 years
Visual Analog Scale
Time frame: Through 3 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 11 Jan 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Chondrogen in people with Recovery Following Partial Medial Meniscectomy, run by Mesoblast International Sàrl at 4 sites in United States.
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 4 inclusion and 0 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Comparison of treatment adverse event rates (time frame: Through 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.