Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- Intensity of adverse reactions at the injection site at day 3
研究概览
简要总结
The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).
详细描述
Autoimmune xerostomia is a disabling condition affecting mostly patients suffering from Sjögren's disease, systemic lupus erythematosus, rheumatoid arthritis and systemic xerostomia.
Local therapies and systemic drug treatments (picarpine) remain the gold standards but have limited effects upon salivary flow action and many adverse effects.
Stem cell therapies and notably adipose tissue-derived stromal cells have shown promising potential for tissue repair. Autologous uncultured adipose-derived stromal vascular fraction (AD-SVF) is recognized as an easily accessible (by a standard lipoaspiration to obtain adipose tissue, from which AD-SVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties.
The purpose of our AD-SVF phase I trial is to evaluate, first the tolerance of autologous AD-SVF cells locally injected in the oral cavity and second their capability to improve the salivary function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 18 to 65 years.
- •Patients suffering from xerostomia and autoimmune disease including : Gougerot-Sjögren disease according to AC/EULAR criteria and Secondary Gougerot-Sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...)
- •Xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30/60
- •Informed consent to participate (with signature)
- •Negative β -HCG test and effective contraception for women being able to get pregnant
- •Affiliation to the social security system
排除标准
- •Medical history of head and neck neoplasia
- •Recent (<3 months) medication inducing and aggravating xerostomia : Standard treatment with tricyclic antidepressant and/or antipsychotics
- •Body Mass Index < 18
- •Active smoking (> 5 cigarettes a day)
- •Active infectious disease and/or active viral serologies (HIV, HCV, HBV, HTLV I/II, TPHA/VDRL)
- •Coagulation disorders including anticoagulant and antiplatelet treatment
- •Any temporary or definitive contraindication due to any medical or surgical unstable condition
- •Allergy to local anesthesia and/or albumin
- •Pregnant or breastfeeding women
- •Adult protected by the law (tutorship and curatorship)
- •Patients already enrolled in another study
- •Patients under 18 years of age
- •Person deprived of liberty
- •Patient non-affiliated to the social security
研究组 & 干预措施
Adult patients suffering from xerostomia and autoimmune disease
Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward :
- The plastic/maxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit;
- The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon;
- The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia.
干预措施: lipoaspiration (Procedure)
Adult patients suffering from xerostomia and autoimmune disease
Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward :
- The plastic/maxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit;
- The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon;
- The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia.
干预措施: Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF) (Drug)
结局指标
主要结局
Intensity of adverse reactions at the injection site at day 3
时间窗: 3 days
3 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment.
Intensity of adverse reactions at the injection site at day 7
时间窗: 7 days
7 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the harvesting site at day 14
时间窗: 14 days
14 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the injection site at day 1
时间窗: 1 day
1 day after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment
Intensity of adverse reactions at the harvesting site at day 1
时间窗: 1 day
1 day after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with phone assessment.
Intensity of adverse reactions at the injection site at day 14
时间窗: 14 days
14 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the harvesting site at day 3
时间窗: 3 days
3 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with phone assessment.
Intensity of adverse reactions at the harvesting site at day 7
时间窗: 7 days
7 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with clinical assessment.
次要结局
- Intensity of adverse reactions at the injection site at month 3(3 months)
- Intensity of adverse reactions at the harvesting site at month 1(1 month)
- Intensity of adverse reactions at the injection site at day 15(15 days)
- Intensity of adverse reactions at the injection site at month 1(1 month)
- Intensity of adverse reactions at the injection site at month 7(7 months)
- Intensity of adverse reactions at the harvesting site at day 15(15 days)
- Intensity of adverse reactions at the injection site at month 6(6 months)
- Intensity of adverse reactions at the harvesting site at month 3(3 months)
- Intensity of adverse reactions at the harvesting site at month 6(6 months)
- Intensity of adverse reactions at the harvesting site at month 7(7 months)
- efficacy of AD-SVF at month 3(3 months)
- efficacy of AD-SVF at month 6(6 months)
- Change in dryness of oral mucosa(3 months)
- primary efficiency of AD-SVF iin term of glands reparation process/repair (Minor salivary gland biopsy)(6 months)
- efficacy of AD-SVF at month 1(1 month)
- Change in xerostomia Visual Analogic Scale (VAS)(6 months)