Systemic SclerosisPhase 2ADUSENCT04356755
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
A Phase 2 study testing AdMSC in people with Systemic Sclerosis, run by University Hospital, Toulouse at 7 sites in France.
Trial summary
Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- AdMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 7 sitesFrance
- Study dates
- 22 Sep 2020to Mar 2027
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient ≥18 years of age,
- Patient with systemic sclerosis according to the 2013 ACR/EULAR classification criteria9,
- SSc patient with at least one refractory active ischemic digital ulcer at "inclusion visit" (see below the eligibility conditions of a DU),
- Age > 50 years and not treated with any kind of hormone replacement therapy for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months prior to screening. An assessment of serum follicle stimulating hormone showing a level of > 40 TU/L at screening may be used to exclude childbearing potential, based on the discretion of the investigator,
- Patient must have provided written informed consent prior to enrolment,
- Patient must be able to understand their requirements of participating in the protocol,
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- Patient affiliated to a social security system.
- Relative to each DU :
- The DU at " inclusion visit " must show all the following characteristics:
- Located beyond the proximal interphalangeal joint, on finger surface (included periungual ulcers),
- Of ischemic origin according to the physician,
- Not over subcutaneous calcifications or bone relief,
- Active DU,
- Refractory after 10±2 weeks of standard of care according to EULAR recommendations26 (that is either still active (chronic) or new occurrence despite standard of care)
Who cannot join
- Current smoker or tobacco consumption stopped for less than 3 months prior to inclusion, - Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,
- Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period,
- Patients on vasodilators, such as endothelin receptor antagonists (ERAs), PDE5 inhibitors (e.g. sildenafil, tadalafil), calcium channel blockers, ACE-inhibitors, nitroglycerin, alpha adrenergic blockers, or angiotensin II receptor antagonists, N-acetylcysteine, antiplatelet aggregation therapy and low molecular weight heparin who have received treatment if present for less than 3 months prior to "inclusion visit" or whose treatment has not been stable for at least 1 month prior to "inclusion visit",
- Treatment with disease modifying agents such as methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, Interferons and cyclophosphamide, those drugs should be stop at least 1 month prior study entry.
- Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent),
- Systemic antibiotics (oral and TV) to treat infected DU(s) within 4 weeks prior to "inclusion visit",
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- Use of topical growth factors, hyperbaric oxygen,
- Local injection of botulinum toxin in an affected finger within 4 weeks prior to "inclusion visit",
- Surgical sympathectomy of the upper limbs or surgical wound debridement within 1 month prior to "inclusion visit",
- Liposuction technically impossible,
- Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year,
- Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national RCP MATHEC),
- History of cancer in the last five years, except for successfully excised basal cell/squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had successfully tumor resection or radiation or chemotherapy more than 5 years from inclusion and no recurrence, may be enrolled in the study, - Subjects who have active proliferative retinopathy,
- Positive HIV-1 or 2, HTLV-1 or 2, HBV or HCV,
- Patients with a history of stroke, myocardial infarction or severe arrhythmia in the last 6 months
- Patient who had severe cardiac failure in the last 6 months,
- Females who are pregnant or breastfeeding or plan to do so during the course of this study,
- Patient under judicial protection, - Refusal of the patient to participate in the study.
- Relative to each DU:
- Digital ulcer due to conditions other than scleroderma,
- Non ischemic digital ulcer,
- Ulcers with osteomyelitis, or clinically uncontrolled infection,
- Infected digital ulcer requiring systemic antibiotherapy,
- Digital ulcer requiring urgent surgery.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
Grenoble Hospital
Grenoble
Bernard IMBERT
- Not yet recruiting
Lille Hopsital
Lille
Eric Hachulla
- Not yet recruiting
Marseille Hospital
Marseille
Brigitte Granel
- Not yet recruiting
Montpellier Hospital
Montpellier
Philippe GILPAIN
- Not yet recruiting
Nantes Hospital
Nantes
Christian AGARD
- Not yet recruiting
Poitiers Hospital
Poitiers
Mathieu Puyade
- Recruiting
CHU de Toulouse - Hôpital PURPAN-TSA
Toulouse, 31059
Grégory PUGNET, MD, PHD, 05 61 77 71 26 ext. +33, pugnet.g@chu-toulouse.fr
About this study
Official title: Subcutaneous Injections of Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With Scleroderma
Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.
Read the detailed description
Systemic sclerosis (SSc) is a systemic autoimmune disease characterized by an autoimmune-mediated microangiopathy and progressive fibrosis. Ischemic digital ulcers (DUs) are frequent in the disease course. DUs are an expression of the severity of the microangiopathy. DUs lead to pain, infection, gangrene, autoamputation, impaired hand use and impaired quality of life. The management of DUs is often based on optimal wound care to promote healing and and repeated hospitalizations to perform onerous prostacyclin infusions to reduce pain and accelerate healing. With optimal standard of care, only 60% of DUs are healed after 3 months and 46.2% experiences recurrence during that time among them 11.2% experiences a chronic evolution. No drug has demonstrated a positive effect on refractory DUs healing. The rational underlying the use of cultured adipose-derived stromal cell (AdMSC) in this indication is based on the finding of AdMSC, in vitro and in vivo, angiogenic and anti-inflammatory potential in other ischemic pathologies, with an excellent safety profile. The pilot phase of the ACellDREAM trial demonstrated the feasibility and safety of AdMSC transplantation in patients with non- revascularizable critical limb ischemia and showed improvement in ulcer evolution and wound healing. The EFS-O culture procedure safety is validated and is already in use in ongoing French and European clinical trials. Two pilot studies showed the safety of adipose tissue grafting for scleroderma-Induced DU. The SCLERADEC pilot study outlines the safety, in 12 SSc patients, of the digital injection of adipose- derived stromal vascular fraction, which is a heterogeneous population of cells including only 36% of uncultured AdMSC. An improvement in hand disability, quality of life and DUs was observed, the phase II is ongoing. The hypothesis of the study is that digital injection of AdMSC could be efficacious for scleroderma-induced refractory ischemic DUs healing by digital vascular regeneration in a clinical situation where no alternative therapy is validated.
- Conditions
- Systemic Sclerosis
- Being tested
- AdMSC, Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdMSCDrug
At day 0, patients will have AdMSC injections in their ischemic DU. Patients will be followed-up for 16 weeks
PlaceboDrug
At day 0, patients will have placebo injections in their ischemic DU. Patients will be followed-up for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| AdMSC | Experimental | Subcutaneous injections of cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma Receives: Drug: AdMSC |
| Placebo | Placebo comparator | Subcutaneous injections of placebo comparator to heal refractory ischemic digital ulcers in patients with scleroderma Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of refractory active ischemic digital ulcers healed (complete or partial)
Partial healing is defined as > 50% reduction of the DU area or > 50% re epidermisation of the DU.
Measured: 16 weeks
Composite endpoint combining healing (complete or partial) without recurrence and without local or general complications
Partial healing is defined as > 50% reduction of the DU area or > 50% re epidermisation of the DU.
Local complications resulting from DU worsening:
- Critical ischemic crisis necessitating hospitalization,
- Gangrene, (auto) amputation,
- Failure of conservative management: Surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestation(s),
- Use of parenteral prostanoids after treatment injection,
- Requiring class II, III or IV narcotics or increase in existing dose of > 50 % as compared to baseline,
- Initiation of systemic antibiotics for the treatment of infection attributed to digital ulceration.
General complications will be assessed by:
- Clinical examination
- Patient reported-outcomes
- Laboratory assessments
Measured: 16 weeks
Secondary outcomes (15)
Percentage of participants with Digital Ulcer complete healing
Number of complete ulcer Healing. Complete healing is defined as 100% re-epidermisation.
Measured: 16 weeks
Percentage of participants with Digital Ulcer partial healing
Number of partial ulcer Healing. Partial healing is defined as > 50% reduction of the DU area or > 50% re epidermisation of the DU.
Measured: 16 weeks
Percentage of participants with wound surface reduction <50%
the wound surface reduction is defined by analysis photography
Measured: 16 weeks
Percentage of participants with new Digital Ulcer
Number of patients who do not develop any new DU.
Measured: 16 weeks
Percentage of participants with Digital Ulcer complication
A complication is an infection, gangrene, amputation or a DU requiring IV prostanoids.
Measured: 16 weeks
Change from Baseline in Pain Scores
Evaluation of pain on a Visual Analog Scale. The visual scale measures the intensity of pain on a scale ranging from 0 (no pain) to 10 (maximum pain).
Measured: 16 weeks
Change from Baseline in severity of Raynaud's phenomenon
Change in severity of Raynaud's phenomenon on a Visual Analog Scale. The visual scale is in a form of plastic ruler and measures the severity of Raynaud's phenomenon on a scale ranging from 0 (no pain) to 100 (maximum pain).
Measured: 16 weeks
Change from Baseline in Digital ischaemia
Change in digital ischaemia of the treated fingers on Digital arterial pressure.
Measured: 16 weeks
Change from Baseline in cutaneous ischaemia
Change in cutaneous ischaemia of the treated fingers on transcutaneous oxygen pressure (TcPO2).
Measured: 16 weeks
Change from Baseline in Digital microvascular organisation
Change in digital microvascular organisation of the treated fingers on nailfold capillaroscopy.
Measured: 16 weeks
Change from Baseline in hand functional disability
Evaluation of hand functional disability by the Cochin Hand Function Scale.
Measured: 16 weeks
Change from Baseline in quality of life in systemic sclerosis
Evaluation of quality of life in systemic sclerosis by scleroderma health assesment (SHAQ).
Measured: 16 weeks
Change from Baseline in quality of life
Evaluation of quality of life by the SF36.
Measured: 16 weeks
Change from Baseline in health status
Evaluation of health status by the EQ5D.
Measured: 16 weeks
Vascular biomarkers
Endothelin-1, Endostatin, Endogline, Angiotensin I and II, Tie 1 and 2, V-EGF, sICAM-1, sVCAM, E-selectin, CXCL4 plus anti-AT1R, anti-ETAR, anti Annexin V will be measured out in blood samples by Luminex
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start22 Sep 2020
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégory PUGNET, MD, PHD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356755
- Sponsor's protocol ID
- RC31/17/0447
- Acronym
- ADUSE
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2020
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Injections of Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With Scleroderma
- ClinicalTrials.gov ID
- NCT04356755
- Acronym / sponsor ID
- ADUSE / RC31/17/0447
- Conditions
- Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Apr 2020 (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.
Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.
Detailed description
Systemic sclerosis (SSc) is a systemic autoimmune disease characterized by an autoimmune-mediated microangiopathy and progressive fibrosis. Ischemic digital ulcers (DUs) are frequent in the disease course. DUs are an expression of the severity of the microangiopathy. DUs lead to pain, infection, gangrene, autoamputation, impaired hand use and impaired quality of life. The management of DUs is often based on optimal wound care to promote healing and and repeated hospitalizations to perform onerous prostacyclin infusions to reduce pain and accelerate healing. With optimal standard of care, only 60% of DUs are healed after 3 months and 46.2% experiences recurrence during that time among them 11.2% experiences a chronic evolution. No drug has demonstrated a positive effect on refractory DUs healing. The rational underlying the use of cultured adipose-derived stromal cell (AdMSC) in this indication is based on the finding of AdMSC, in vitro and in vivo, angiogenic and anti-inflammatory potential in other ischemic pathologies, with an excellent safety profile. The pilot phase of the ACellDREAM trial demonstrated the feasibility and safety of AdMSC transplantation in patients with non- revascularizable critical limb ischemia and showed improvement in ulcer evolution and wound healing. The EFS-O culture procedure safety is validated and is already in use in ongoing French and European clinical trials. Two pilot studies showed the safety of adipose tissue grafting for scleroderma-Induced DU. The SCLERADEC pilot study outlines the safety, in 12 SSc patients, of the digital injection of adipose- derived stromal vascular fraction, which is a heterogeneous population of cells including only 36% of uncultured AdMSC. An improvement in hand disability, quality of life and DUs was observed, the phase II is ongoing. The hypothesis of the study is that digital injection of AdMSC could be efficacious for scleroderma-induced refractory ischemic DUs healing by digital vascular regeneration in a clinical situation where no alternative therapy is validated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AdMSC | Experimental | Drug: AdMSCSubcutaneous injections of cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injections of placebo comparator to heal refractory ischemic digital ulcers in patients with scleroderma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patient ≥18 years of age,
- Patient with systemic sclerosis according to the 2013 ACR/EULAR classification criteria9,
- SSc patient with at least one refractory active ischemic digital ulcer at "inclusion visit" (see below the eligibility conditions of a DU),
- Age > 50 years and not treated with any kind of hormone replacement therapy for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months prior to screening. An assessment of serum follicle stimulating hormone showing a level of > 40 TU/L at screening may be used to exclude childbearing potential, based on the discretion of the investigator,
- Patient must have provided written informed consent prior to enrolment,
Key exclusion criteria (24 listed)
- Current smoker or tobacco consumption stopped for less than 3 months prior to inclusion, - Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,
- Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period,
- Patients on vasodilators, such as endothelin receptor antagonists (ERAs), PDE5 inhibitors (e.g. sildenafil, tadalafil), calcium channel blockers, ACE-inhibitors, nitroglycerin, alpha adrenergic blockers, or angiotensin II receptor antagonists, N-acetylcysteine, antiplatelet aggregation therapy and low molecular weight heparin who have received treatment if present for less than 3 months prior to "inclusion visit" or whose treatment has not been stable for at least 1 month prior to "inclusion visit",
- Treatment with disease modifying agents such as methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, Interferons and cyclophosphamide, those drugs should be stop at least 1 month prior study entry.
- Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent),
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 |
|---|---|---|
| AdMSCAt day 0, patients will have AdMSC injections in their ischemic DU. Patients will be followed-up for 16 weeks | Drug | AdMSC |
| PlaceboAt day 0, patients will have placebo injections in their ischemic DU. Patients will be followed-up for 16 weeks | Drug | Placebo |
Primary outcome
Proportion of refractory active ischemic digital ulcers healed (complete or partial)
Time frame: 16 weeks
Partial healing is defined as > 50% reduction of the DU area or > 50% re epidermisation of the DU.
Composite endpoint combining healing (complete or partial) without recurrence and without local or general complications
Time frame: 16 weeks
Partial healing is defined as > 50% reduction of the DU area or > 50% re epidermisation of the DU. Local complications resulting from DU worsening: * Critical ischemic crisis necessitating hospitalization, * Gangrene, (auto) amputation, * Failure of conservative management: Surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestation(s), * Use of parenteral prostanoids after treatment injection, * Requiring class II, III or IV narcotics or increase in existing dose of > 50 % as compared to baseline, * Initiation of systemic antibiotics for the treatment of infection attributed to digital ulceration. General complications will be assessed by: * Clinical examination * Patient reported-outcomes * Laboratory assessments
15 secondary outcomes
Percentage of participants with Digital Ulcer complete healing
Time frame: 16 weeks
Percentage of participants with Digital Ulcer partial healing
Time frame: 16 weeks
Percentage of participants with wound surface reduction <50%
Time frame: 16 weeks
Percentage of participants with new Digital Ulcer
Time frame: 16 weeks
Percentage of participants with Digital Ulcer complication
Time frame: 16 weeks
Change from Baseline in Pain Scores
Time frame: 16 weeks
Change from Baseline in severity of Raynaud's phenomenon
Time frame: 16 weeks
Change from Baseline in Digital ischaemia
Time frame: 16 weeks
Change from Baseline in cutaneous ischaemia
Time frame: 16 weeks
Change from Baseline in Digital microvascular organisation
Time frame: 16 weeks
Change from Baseline in hand functional disability
Time frame: 16 weeks
Change from Baseline in quality of life in systemic sclerosis
Time frame: 16 weeks
Change from Baseline in quality of life
Time frame: 16 weeks
Change from Baseline in health status
Time frame: 16 weeks
Vascular biomarkers
Time frame: 16 weeks
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 31 Dec 2025.
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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.
Grégory PUGNET, MD, PHD principal investigator
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AdMSC in people with Systemic Sclerosis, run by University Hospital, Toulouse at 7 sites 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 14 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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 phase mean?
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 Grégory PUGNET, MD, PHD (05 61 77 71 26 ext. +33, pugnet.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of refractory active ischemic digital ulcers healed (complete or partial) (time frame: 16 weeks). The study lists 2 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 31 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.