2024-518516-39-00招募中2 期
Efficacy and safety of allogenic cultured Adipose-derived mesenchymal stromal cell injections on MoUth fibrosis and handicap in patients with Systemic sclEroderma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- the change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) between baseline and week 12; An improvement of at least 5 points will be considered clinically significant
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
the change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) between baseline and week 12; An improvement of at least 5 points will be considered clinically significant
the change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) between baseline and week 12; An improvement of at least 5 points will be considered clinically significant
次要结局
- Change in maximum interincisal distance and mouth perimeter
- The safety throughout the course of the study (until week 24 since baseline) will be assessed by monitoring adverse events, serious adverse events and injection site reactions
- Change in Opening, Dryness and Aesthetic of the 3 subscales of the MHISS;
- Change in psycho-social aspects and oro-facial pains by EDAS21, Epworth at W4, W12 and W24 and Combadazou-Destruhaut questionnaire (only at Toulouse) at W12 and W24 and drawings of consciousness (only at Toulouse) at W24
- Change in patient-reported outcomes (patient satisfaction assessment (the patients will be asked to fill in a simple questionnaire where their degree of satisfaction could be expressed by a semiquantitative score (unsatisfied, mildly/moderately satisfied, rather satisfied, and very satisfied), sHAQ, OHAT, BOFA questionnaire and EQ-5D-5L at W4, W12 and W24;
- Change in oral habits and hygiene measured by oral health and hygiene questionnaire at W24
- Change in oral microbiota (only at Toulouse) at W12 and 24
- Change in Plaque index (reflecting the ability to maintain oral hygiene) at W12 an W24 (only at Toulouse),
- Change in DMFT (decayed missing filled teeth) and Panoramic x-ray at W24;
- Change in mandibular tracking (only at Toulouse at W4, W12 and W24 and articular and neuro-muscular activity (only at Toulouse) at W12 and W24
- Change posture by stabilometry (only at Toulouse) at W12 and W24
- Change in modified Rodnan skin score at W12 and W24;
- Change in dry mouth syndrome at W4, W12 and W24 (Change in Xerostomia Inventory questionnaire; Change in Salivary flow; Change in the salivary pH
- Change in Standardised two-dimensional photographs or facial scan at Toulouse at W4,12 and 24
- Change in immunomonitoring of vascular and antifibrotic biomarkers expression at W12;
- Not an evaluation criterion but the creation of a serum, plasma biobank at baseline, W12 and W24).
- Not an evaluation criterion but the creation of oral microbiota biobank (only at Toulouse at W12 and W24)
研究者
principal investigator
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (5)
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