NCT03378414

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

A Clinical Research on the Safety/Efficacy of Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Spinocerebellar Ataxia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Spinocerebellar Ataxia Type 1
• Spinocerebellar Ataxia Type 2
• Spinocerebellar Ataxia Type 3
• Spinocerebellar Ataxia Type 6

Interventions

Type	Name	Description
PROCEDURE	Intravenous infusion	Intravenous infusion of mesenchymal stem cells: 2 \* 10\^7 cells (30ml)
PROCEDURE	Intrathecal injection	Intrathecal injection of mesenchymal stem cells: 2 \* 10\^7 cells (1ml)
BIOLOGICAL	umbilical cord mesenchymal stem cell	Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), the dosage based on different procedure

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2017-12-19
• Last updated: 2025-12-04