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New treatment option for Systemic Sclerosis
Official title Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
ClinicalTrials.gov ID: NCT04356755
What this study is testing
What is AdMSC?
AdMSC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient must have provided written informed consent prior to enrolment,
You likely can't join if
- Current smoker or tobacco consumption stopped for less than 3 months prior to inclusion, - Patient participating in a clinical trial or having...
- 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...
- Treatment with disease modifying agents such as methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, Interferons and cyclophosphamide...
- 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",
See the full eligibility criteria
- 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...
- Patient must have provided written informed consent prior to enrolment,
- Patient must be able to understand their requirements of participating in the protocol,
- 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)
- 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...
- 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",
- 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. people, who had successfully tumor resection or radiation...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, France
- Lille, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Poitiers, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, France; Lille, France; Marseille, France; Montpellier, France; Nantes, France; Poitiers, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.