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Предстои набиране Фаза 2 NCT03378414

Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-SA) for Patients With Spinocerebellar Ataxia

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6

Спонсор: Sclnow Biotechnology Co., Ltd.

Налично на: БГ
Обобщение
The purpose of this study is verify the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Spinocerebellar Ataxia, and in addition, explore the possible mechanisms of UC-MSC therapy in Spinocerebellar Ataxia.
Описание
This is a random, open label, and parallel controled experiment. 45 patients are selected and sign consent forms, then divided into three groups. Doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, genotype test, and so on.) All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 1, 2, 3, 6, and 12 months after treatment, and do efficacy evaluation.
Кой може да участва
Inclusion Criteria: * Clinical and genomic test diagnoses as spinocerebellar ataxias (SCA) (include SCA 1, SCA 2, SCA 3, SCA 6), SARA (Scale for Assessment and Rating of Ataxia) score is 2-5, can complete 8-meter walking test(8MW) * Do not receive stem cells treatment in 6 months * Participants sign the consent form based on the experiment process and statement Exclusion Criteria: * Cardiac, renal, hepatic insufficiency; total bilirubin is 1.5 times higher than normal value, aspartate transaminase(AST)or alanine aminotransferase(ALT)is 2.5 times higher than normal value * Hemogram: total white blood cells \<3.0 \* 10\^9 cells/L, blood platelet \<75 \* 10\^9/L, hemoglobin \<100g/L * pneumonia, or severe infection * With severe allergic history * Brain organic disorder, like brain tumor * Serum with HIV, syphilis antibody positive * Severe mental disease, cognitive disorder patients * Other severe system or organ organic disease * Pregnant, breast feeding, or planning pregnant women * Participate other clinical experiments in 3 months * With some other conditions that doctor propose not to participate
Интервенции
Intravenous infusion
PROCEDURE
Intrathecal injection
PROCEDURE
umbilical cord mesenchymal stem cell
BIOLOGICAL
Места на провеждане

Информация за локации не е налична.

Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
16 Years
Максимална възраст
60 Years
Здрави доброволци
Не
Начална дата
31.12.2026
Крайна дата
31.12.2027
Регистрационен номер
NCT03378414
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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