Hemophilia ANCT05187936
Pre-clinical Models for Mesenchymal Stem Cell Therapy in Hemophilic Arthropathy
An observational study of Hemophilia A and Hemophilia B, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Hemophilia is a constitutional coagulation disorder responsible for a hemorrhagic phenotype in patients from an early age. Hemarthrosis is one of the most frequent complications in hemophiliacs and leads to the development of severe and early arthropathy, sometimes as early as childhood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A, Hemophilia B, Arthropathy
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 31 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hemophilia A or B patient, with or without arthropathy
Who may be able to join
- Hemophilia A or B adult patient, with or without arthropathy
- Heathly control
Who cannot join
- Antiinflammatory drug use
- immunosuppressive treatment or condition
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Alexandre THERON, MD, 467336519 ext. 33, a-theron@chu-montpellier.fr
About this study
Hemophilia is a constitutional coagulation disorder responsible for a hemorrhagic phenotype in patients from an early age. Hemarthrosis is one of the most frequent complications in hemophiliacs and leads to the development of severe and early arthropathy, sometimes as early as childhood. To date, there is no curative treatment for these joint disorders and preventive treatments are insufficient to completely prevent joint degradation. Mesenchymal stem cells have been shown to be of therapeutic interest in the management of pathologies such as osteoarthritis and inflammatory arthritis through their anti-inflammatory, regenerative and anti-apoptotic effects. Hemophilic arthropathy is a separate condition at the border of these two diseases Our study aim to show pre-clinical interest of mesenchymal stem cell therapy in hemophilic arthropathy
- Conditions
- Hemophilia A, Hemophilia B, Arthropathy
- Keywords
- mesenchymal stem cells, Healthly control
- Medical subject headings
- Hemophilia A, Hemophilia B, Joint Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of surviva
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Measured: 1 day
Evaluation of proliferation
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Measured: 1 day
Evaluation of apoptosis, phenotype, function of cells
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Measured: 1 day
Evaluation of phenotype
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre THERON, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187936
- Sponsor's protocol ID
- RECHMPL21_0640
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-clinical Models for Mesenchymal Stem Cell Therapy in Hemophilic Arthropathy
- ClinicalTrials.gov ID
- NCT05187936
- Acronym / sponsor ID
- RECHMPL21_0640
- Conditions
- Hemophilia A, Hemophilia B, Arthropathy
- Keywords
- mesenchymal stem cells, Healthly control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- 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.
Hemophilia is a constitutional coagulation disorder responsible for a hemorrhagic phenotype in patients from an early age. Hemarthrosis is one of the most frequent complications in hemophiliacs and leads to the development of severe and early arthropathy, sometimes as early as childhood. To date, there is no curative treatment for these joint disorders and preventive treatments are insufficient to completely prevent joint degradation. Mesenchymal stem cells have been shown to be of therapeutic interest in the management of pathologies such as osteoarthritis and inflammatory arthritis through their anti-inflammatory, regenerative and anti-apoptotic effects. Hemophilic arthropathy is a separate condition at the border of these two diseases Our study aim to show pre-clinical interest of mesenchymal stem cell therapy in hemophilic arthropathy
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hemophilia A or B patient, with or without arthropathy
Key inclusion criteria (2 listed)
- Hemophilia A or B adult patient, with or without arthropathy
- Heathly control
Key exclusion criteria (2 listed)
- Antiinflammatory drug use
- immunosuppressive treatment or condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of surviva
Time frame: 1 day
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Evaluation of proliferation
Time frame: 1 day
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Evaluation of apoptosis, phenotype, function of cells
Time frame: 1 day
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Evaluation of phenotype
Time frame: 1 day
Use of blood or its derivatives for in vitro studies using different types of cells (chondrocytes, mesenchymal stromal cells, synoviocytes,...). Evaluation of survival, proliferation, apoptosis, phenotype, function of cells using relevant tests including RT-qPCR, flow cytometry,ELISA and other dedicated biochemical assays.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Alexandre THERON principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 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 1 site in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre THERON, MD (467336519 ext. 33, a-theron@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of surviva (time frame: 1 day). The study lists 4 primary outcomes in all. 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 12 Jan 2022.