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Набор скоро начнётся NCT07326033

Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma

Фаза II С лечением Systemic Scleroderma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AdMSC, Placebo.
Кому может быть актуально
Состояния в реестре: Systemic Scleroderma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

Orofacial manifestations and microstomia are a frequent complication in systemic sclerosis (SSc) with a major impact on oral hygiene, dental care and quality of life. Peri-oral injection of allogeneic cultured adipose-derived stromal cells constitutes a promising approach to treat scleroderma-induced mouth fibrosis where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of perioral injection of allogeneic cultured adipose-derived stromal cells (AdMSC) versus placebo to improve oro-facial fibrosis in patients with systemic sclerosis.

Вмешательства

  • Препарат AdMSC
    At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks
  • Препарат Placebo
    At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks

Первичные конечные точки

  • Change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) [Срок оценки: Day 0, 12 weeks after injection]
Вторичные конечные точки (12)
  • Safety of treatment [Срок оценки: Day 0, 4, 12 and 24 weeks after injection]
  • Efficacy on oral function by facial scanners [Срок оценки: Day 0, 4, 12 and 24 weeks after injection]
  • Efficacy on orofacial handicap [Срок оценки: Day 0, 4, 12 and 24 weeks after injection]
  • Patient satisfaction [Срок оценки: Day 0, 4, 12 and 24 weeks after injection]
  • Oral habits and hygiene [Срок оценки: Day 0 and 24 weeks after injection]
  • oral microbiota [Срок оценки: Day 0, 12 and 24 weeks after injection]
  • Plaque index [Срок оценки: Day 0, 12 and 24 weeks after injection]
  • Change in decayed missing filled teeth [Срок оценки: Day 0 and 24 weeks after injection]
  • Change in mandibular tracking [Срок оценки: Day 0, 4, 12 and 24 weeks after injection]
  • Posture by stabilometry [Срок оценки: Day 0, 12 and 24 weeks after injection]
  • psycho-social aspects and oro-facial pains [Срок оценки: Day 0, 4, 12 and 24 weeks after injection]
  • Rodnan skin score [Срок оценки: Day 0, 12 and 24 weekds after injection]

Критерии участия

Критерии включения

  • 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 their requirements of participating in the protocol.
  • Patient affiliated to a social security system.

Критерии исключения

  • Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,
  • 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 successfully excised basal cell/squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had a successful 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,
  • Vulnerable patient (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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Франция · 5 центров
  • Bordeaux Hospital — Bordeaux
  • Dijon Hospital — Dijon
  • Montpellier Hospital — Montpellier
  • Nantes Hospital — Nantes
  • Toulouse Hospital — Toulouse

Идентификаторы

NCT: NCT07326033 · RC31/22/0258 · 2024-518516-39-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗