XerostomiaPhase 1/2XEROCELLNCT05857358
Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia
A Phase 1/2 study testing lipoaspiration and Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF) in people with Xerostomia, run by Assistance Publique Hopitaux De Marseille.
Trial summary
The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Xerostomia
- What is being tested?
- lipoaspiration and Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from 18 to 65 years.
- Patients suffering from xerostomia and autoimmune disease including : Gougerot-Sjögren disease according to AC/EULAR criteria and Secondary Gougerot-Sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...)
- Xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30/60
- Informed consent to participate (with signature)
- Negative β -HCG test and effective contraception for women being able to get pregnant
- Affiliation to the social security system
Who cannot join
- Medical history of head and neck neoplasia
- Recent (<3 months) medication inducing and aggravating xerostomia : Standard treatment with tricyclic antidepressant and/or antipsychotics
- Body Mass Index < 18
- Active smoking (> 5 cigarettes a day)
- Active infectious disease and/or active viral serologies (HIV, HCV, HBV, HTLV I/II, TPHA/VDRL)
- Coagulation disorders including anticoagulant and antiplatelet treatment
Show all 14Show fewer
- Any temporary or definitive contraindication due to any medical or surgical unstable condition
- Allergy to local anesthesia and/or albumin
- Pregnant or breastfeeding women
- Adult protected by the law (tutorship and curatorship)
- Patients already enrolled in another study
- Patients under 18 years of age
- Person deprived of liberty
- Patient non-affiliated to the social security
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).
Read the detailed description
Autoimmune xerostomia is a disabling condition affecting mostly patients suffering from Sjögren's disease, systemic lupus erythematosus, rheumatoid arthritis and systemic xerostomia.
Local therapies and systemic drug treatments (picarpine) remain the gold standards but have limited effects upon salivary flow action and many adverse effects.
Stem cell therapies and notably adipose tissue-derived stromal cells have shown promising potential for tissue repair. Autologous uncultured adipose-derived stromal vascular fraction (AD-SVF) is recognized as an easily accessible (by a standard lipoaspiration to obtain adipose tissue, from which AD-SVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties.
The purpose of our AD-SVF phase I trial is to evaluate, first the tolerance of autologous AD-SVF cells locally injected in the oral cavity and second their capability to improve the salivary function.
- Conditions
- Xerostomia
- Being tested
- lipoaspiration, Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipoaspirationProcedure or surgery
Adipose tissue harvest will be conducted by a surgeon under under local and intra-veinous sedation anesthesia. Once the patient is asleep and just before the laying of the operating drapes, the skin will be thoroughly disinfected, in order to avoid bacteriological contamination. Each entry point will be disinfected with betadine before and regularly during the procedure and will receive local anesthesia.
The lipoaspiration sites will be infiltrated using a closed system, thanks to a Khoury canula. Adipose tissue will be harvested after waiting at least 5 minutes, in order to limit hematoma and excessive blood harvesting. A 3mm incision will be made then the tissue collection will be performed using a canula, manually, by gentle aspirations into a syringe then directly transferred into a connected sterile bag.
The incision will be closed with 1 stitch of 6-0 absorbable and a paraffin gauze dressing. Then, patient will be awaken and transported to the recovery room.
Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)Drug
Autologous uncultured (AD-SVF) will be isolated by digestion and centrifugation of adipose tissue from lipoaspiration.
Then, AD-SVF will be injected in 6 sites :
- 2 for the accessory labial glands (0.5mL in the upper lip and 0.5mL in the lower lip)
- 2 for the sublingual glands (0.5mL for each gland)
- 2 for the inner face of cheeks (0.5mL for each side)
The volume of injection will be of 3 mL containing 30 millions of AD-SVF viable nucleated cells for the total safety dose.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients suffering from xerostomia and autoimmune disease | Experimental | Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward :
* The plastic/maxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit;
* The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon;
* The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia. Receives: Procedure: lipoaspiration; Drug: Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of adverse reactions at the injection site at day 1
1 day after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment
Measured: 1 day
Intensity of adverse reactions at the injection site at day 3
3 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment.
Measured: 3 days
Intensity of adverse reactions at the injection site at day 7
7 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Measured: 7 days
Intensity of adverse reactions at the injection site at day 14
14 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Measured: 14 days
Intensity of adverse reactions at the harvesting site at day 1
1 day after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with phone assessment.
Measured: 1 day
Intensity of adverse reactions at the harvesting site at day 3
3 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with phone assessment.
Measured: 3 days
Intensity of adverse reactions at the harvesting site at day 7
7 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with clinical assessment.
Measured: 7 days
Intensity of adverse reactions at the harvesting site at day 14
14 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
Measured: 14 days
Secondary outcomes (16)
Intensity of adverse reactions at the injection site at day 15
15 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Measured: 15 days
Intensity of adverse reactions at the injection site at month 1
1 month after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Measured: 1 month
Intensity of adverse reactions at the injection site at month 3
3 months after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Measured: 3 months
Intensity of adverse reactions at the injection site at month 6
6 months after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Measured: 6 months
Intensity of adverse reactions at the injection site at month 7
7 months after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Measured: 7 months
Intensity of adverse reactions at the harvesting site at day 15
15 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
Measured: 15 days
Intensity of adverse reactions at the harvesting site at month 1
1 month after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
Measured: 1 month
Intensity of adverse reactions at the harvesting site at month 3
3 months after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
Measured: 3 months
Intensity of adverse reactions at the harvesting site at month 6
6 months after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
Measured: 6 months
Intensity of adverse reactions at the harvesting site at month 7
7 months after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
Measured: 7 months
primary efficiency of AD-SVF iin term of glands reparation process/repair (Minor salivary gland biopsy)
A minor salivary gland biopsy will be done under local anaesthesia 6 months after the injection. Then, an Histological analysis (4 grades Chilson-Mason score) of minor salivary gland biopsy will be performed.
Measured: 6 months
efficacy of AD-SVF at month 1
Salivary flow will be collected after stimulation 1 month after the injection. It is expressed in milliliter by minutes after 5 minutes of collect, and oligoptyalism isdefined by a salivary flow < 0.1 mL/mn at rest, and < 0.7 ml/mn after stimulation.
Measured: 1 month
efficacy of AD-SVF at month 3
Salivary flow will be collected after stimulation 3 months after the injection. It is expressed in milliliter by minutes after 5 minutes of collect, and oligoptyalism isdefined by a salivary flow < 0.1 mL/mn at rest, and < 0.7 ml/mn after stimulation.
Measured: 3 months
efficacy of AD-SVF at month 6
Salivary flow will be collected after stimulation 6 months after the injection. It is expressed in milliliter by minutes after 5 minutes of collect, and oligoptyalism isdefined by a salivary flow < 0.1 mL/mn at rest, and < 0.7 ml/mn after stimulation.
Measured: 6 months
Change in dryness of oral mucosa
Change in dryness of oral mucosa will be assessed from Clinical Oral Dryness Score (CODS) based on 10 items realized before and, 3 and 6 months after the injection.
Measured: 3 months
Change in xerostomia Visual Analogic Scale (VAS)
Change in VAS will be assessed from a 6-items questionnaire scored from 0 to 10 (increasing gravity) according to Likert scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study startJan 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857358
- Sponsor's protocol ID
- 2023-505149-20-00
- Other IDs
- 2023
- Acronym
- XEROCELL
- Status last verified
- Nov 2023
- First submitted
- 14 Apr 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
- ClinicalTrials.gov ID
- NCT05857358
- Acronym / sponsor ID
- XEROCELL / 2023-505149-20-00
- Conditions
- Xerostomia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 12 May 2023 (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.
The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).
Detailed description
Autoimmune xerostomia is a disabling condition affecting mostly patients suffering from Sjögren's disease, systemic lupus erythematosus, rheumatoid arthritis and systemic xerostomia.
Local therapies and systemic drug treatments (picarpine) remain the gold standards but have limited effects upon salivary flow action and many adverse effects.
Stem cell therapies and notably adipose tissue-derived stromal cells have shown promising potential for tissue repair. Autologous uncultured adipose-derived stromal vascular fraction (AD-SVF) is recognized as an easily accessible (by a standard lipoaspiration to obtain adipose tissue, from which AD-SVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties.
The purpose of our AD-SVF phase I trial is to evaluate, first the tolerance of autologous AD-SVF cells locally injected in the oral cavity and second their capability to improve the salivary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients suffering from xerostomia and autoimmune disease | Experimental | Procedure: lipoaspiration, Drug: Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward : * The plastic/maxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit; * The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon; * The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients from 18 to 65 years.
- Patients suffering from xerostomia and autoimmune disease including : Gougerot-Sjögren disease according to AC/EULAR criteria and Secondary Gougerot-Sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...)
- Xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30/60
- Informed consent to participate (with signature)
- Negative β -HCG test and effective contraception for women being able to get pregnant
Key exclusion criteria (14 listed)
- Medical history of head and neck neoplasia
- Recent (<3 months) medication inducing and aggravating xerostomia : Standard treatment with tricyclic antidepressant and/or antipsychotics
- Body Mass Index < 18
- Active smoking (> 5 cigarettes a day)
- Active infectious disease and/or active viral serologies (HIV, HCV, HBV, HTLV I/II, TPHA/VDRL)
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 |
|---|---|---|
| lipoaspirationAdipose tissue harvest will be conducted by a surgeon under under local and intra-veinous sedation anesthesia. Once the patient is asleep and just before the laying of the operating drapes, the skin will be thoroughly disinfected, in order to avoid bacteriological contamination. Each entry point will be disinfected with betadine before and regularly during the procedure and will receive local anesthesia. The lipoaspiration sites will be infiltrated using a closed system, thanks to a Khoury canula. Adipose tissue will be harvested after waiting at least 5 minutes, in order to limit hematoma and excessive blood harvesting. A 3mm incision will be made then the tissue collection will be performed using a canula, manually, by gentle aspirations into a syringe then directly transferred into a connected sterile bag. The incision will be closed with 1 stitch of 6-0 absorbable and a paraffin gauze dressing. Then, patient will be awaken and transported to the recovery room. | Procedure or surgery | Adult patients suffering from xerostomia and autoimmune disease |
| Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)Autologous uncultured (AD-SVF) will be isolated by digestion and centrifugation of adipose tissue from lipoaspiration. Then, AD-SVF will be injected in 6 sites : * 2 for the accessory labial glands (0.5mL in the upper lip and 0.5mL in the lower lip) * 2 for the sublingual glands (0.5mL for each gland) * 2 for the inner face of cheeks (0.5mL for each side) The volume of injection will be of 3 mL containing 30 millions of AD-SVF viable nucleated cells for the total safety dose. | Drug | Adult patients suffering from xerostomia and autoimmune disease |
Primary outcome
Intensity of adverse reactions at the injection site at day 1
Time frame: 1 day
1 day after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment
Intensity of adverse reactions at the injection site at day 3
Time frame: 3 days
3 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment.
Intensity of adverse reactions at the injection site at day 7
Time frame: 7 days
7 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the injection site at day 14
Time frame: 14 days
14 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the harvesting site at day 1
Time frame: 1 day
1 day after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with phone assessment.
Intensity of adverse reactions at the harvesting site at day 3
Time frame: 3 days
3 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with phone assessment.
Intensity of adverse reactions at the harvesting site at day 7
Time frame: 7 days
7 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with clinical assessment.
Intensity of adverse reactions at the harvesting site at day 14
Time frame: 14 days
14 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
16 secondary outcomes
Intensity of adverse reactions at the injection site at day 15
Time frame: 15 days
Intensity of adverse reactions at the injection site at month 1
Time frame: 1 month
Intensity of adverse reactions at the injection site at month 3
Time frame: 3 months
Intensity of adverse reactions at the injection site at month 6
Time frame: 6 months
Intensity of adverse reactions at the injection site at month 7
Time frame: 7 months
Intensity of adverse reactions at the harvesting site at day 15
Time frame: 15 days
Intensity of adverse reactions at the harvesting site at month 1
Time frame: 1 month
Intensity of adverse reactions at the harvesting site at month 3
Time frame: 3 months
Intensity of adverse reactions at the harvesting site at month 6
Time frame: 6 months
Intensity of adverse reactions at the harvesting site at month 7
Time frame: 7 months
primary efficiency of AD-SVF iin term of glands reparation process/repair (Minor salivary gland biopsy)
Time frame: 6 months
efficacy of AD-SVF at month 1
Time frame: 1 month
efficacy of AD-SVF at month 3
Time frame: 3 months
efficacy of AD-SVF at month 6
Time frame: 6 months
Change in dryness of oral mucosa
Time frame: 3 months
Change in xerostomia Visual Analogic Scale (VAS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lipoaspiration and Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF) in people with Xerostomia, run by Assistance Publique Hopitaux De Marseille.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Guyot, Pr (04 91 43 63 13, Laurent.guyot@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of adverse reactions at the injection site at day 1 (time frame: 1 day). The study lists 8 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 18 Nov 2023.