NCT06397274尚未招募2 期
A Phase II, Randomized, Double-Blind, Placebo-controlled, Single-Center Study to Evaluate the Safety and Efficacy of Stemchymal (Allogeneic Adipose-derived Mesenchymal Stem Cells) Infusion for the Treatment of PolyQ Spinocerebellar Ataxia
Steminent US, Inc.0 个研究点目标入组 20 人开始时间: 2025年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Change of Scale for the Assessment and Rating of Ataxia (SARA) scores from baseline (week 0) at 6 months (week 24).
研究概览
简要总结
The purpose of the clinical trial is to study the therapeutic efficacy and safety of Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized, double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal® through intravenous infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are with genotypically confirmed SCA
- •Subjects' SARA scores are in the range of 5 to
- •Subjects are between 20 and 70 years of age.
- •Subjects who have signed informed consent.
- •Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing effective methods of birth control.
- •Male subjects must be practicing a medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception.
排除标准
- •Subjects who have been enrolled in any kind of cell therapy within six months prior to screening visit (Visit 1).
- •Female subjects who have a positive pregnancy test result.
- •Subjects who have had severe vital organ diseases, including but not limited to cardiac (e.g., heart failure), liver (e.g., acute hepatic failure or chronic liver cirrhosis), lung (e.g., respiratory failure) and renal (e.g., hemodialysis or peritoneal dialysis) diseases, within six months prior to screening visit (Visit 1).
- •Subjects with immunological disorders (e.g., systemic lupus erythematosus), within six months prior to screening visit (Visit 1).
- •Subjects with other neurological disorders (e.g., Alzheimer's disease), within six months prior to screening visit (Visit 1).
- •Subjects who had received chemotherapy/radiotherapy within five years prior to screening visit (Visit 1).
- •Subjects with any history of malignant tumors.
- •Subjects with dementia or other psychiatric illnesses, including but not limited to disabling depression, bipolar disorder, schizophrenia.
- •Subjects with a Beck Depression Inventory Second Edition (BDI-II) score of over 20 points.
- •Subjects not suitable for this clinical trial according to investigator's judgment.
结局指标
主要结局
Change of Scale for the Assessment and Rating of Ataxia (SARA) scores from baseline (week 0) at 6 months (week 24).
时间窗: 6 months
次要结局
未报告次要终点
研究者
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