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Efficacy and safety of allogenic cultured Adipose-derived mesenchymal stromal cell injections on MoUth fibrosis and handicap in patients with Systemic sclEroderma
EU CTIS ID: 2024-518516-39-00
What this study is testing
To assess efficacy of allogenic cultured adipose-derived stromal cell injections on orofacial fibrosis and handicap at week 12 in patients with systemic scleroderma, as measured by the MHISS scale.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patient ≥18 years of age
- Patient with systemic scleroderma according to the 2013 ACR/EULAR classification criteria
- Mouth Handicap in Systemic Sclerosis Scale (MHISS) score more than or equal to 20 (0–48)
- Rodnan skin score on the face more than or equal to 1
- Maximal mouth opening of less than 40 mm (distance between the dental arches)
- Patient must have provided written informed consent prior to enrolment
You likely can't join if
- Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months
- Vulnerable patients (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code)
- Injection of botulinum toxin within 4 weeks prior to “inclusion visit”
- Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year
- Local active labial herpes virus within 1 week prior to “inclusion visit”,
- Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national MATHEC-SFGMTC guidelines),
See the full eligibility criteria
- Male or female patient ≥18 years of age
- Patient with systemic scleroderma according to the 2013 ACR/EULAR classification criteria
- Mouth Handicap in Systemic Sclerosis Scale (MHISS) score more than or equal to 20 (0–48)
- Rodnan skin score on the face more than or equal to 1
- Maximal mouth opening of less than 40 mm (distance between the dental arches)
- Patient must have provided written informed consent prior to enrolment
- Patient must be able to understand the requirements of participating in the protocol
- Patient affiliated to a social security system
- Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months
- Vulnerable patients (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code)
- Injection of botulinum toxin within 4 weeks prior to “inclusion visit”
- Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year
- Local active labial herpes virus within 1 week prior to “inclusion visit”,
- Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national MATHEC-SFGMTC guidelines),
- History of cancer in the last five years, except for successful 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 prior to inclusion and no recurrence, may be enrolled in the study,
- Radio- or chemotherapy in progress
- Females who are pregnant or breastfeeding or plan to be or do so during the course of this study,
- Women of childbearing potential (WOCBP) who are sexually active and unwilling to use an adequate birth control method
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.