ClinicalTrials.gov record NCT03378414

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age16 years old to 60 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, open-label Phase 2 study compares two ways of giving umbilical cord mesenchymal stem cells (intravenous infusion or intrathecal injection) with a no-intervention control in people with spinocerebellar ataxia types 1, 2, 3, or 6. Forty-five participants are assigned to one of three groups and have baseline exams plus follow-up visits at 1, 2, 3, 6, and 12 months. The main outcome is change on the Scale for the Assessment and Rating of Ataxia (SARA) at 12 months.

What it is studying. The study aims to verify the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) therapy in people with SCA, compare intravenous versus intrathecal administration, and explore possible biological mechanisms of treatment.

What the researchers hope to learn. To assess safety and efficacy of UC-MSC therapy in spinocerebellar ataxia, compare two routes of administration, and investigate changes on brain MRI, non-ataxia symptom scores (INAS), and cerebrospinal fluid over 12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological: umbilical cord mesenchymal stem cell
Procedure: Intravenous infusion
Intrathecal injection

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After baseline medical history, lab tests and brain imaging, participants are randomized to one of three groups: an intravenous infusion of umbilical cord mesenchymal stem cells (2 × 10^7 cells, 30 mL), an intrathecal (spinal) injection of the same cells (2 × 10^7 cells, 1 mL), or a no‑intervention control group. Intrathecal injection is a spinal procedure and is an invasive part of the study for that arm. Study visits include evaluations at 1, 2, 3, 6, and 12 months after treatment with ataxia rating scales (SARA), walking tests, MRI brain scans, cerebrospinal fluid routine checks (as listed), and safety monitoring.

How the study is structured. Randomized, open-label, parallel Phase 2 trial with three groups: intravenous UC-MSC infusion (2 × 10^7 cells, 30 ml), intrathecal UC-MSC injection (2 × 10^7 cells, 1 ml), and a no-intervention control. Participants have baseline testing and follow-up visits at 1, 2, 3, 6, and 12 months; the primary measure is SARA score change at 12 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on spinocerebellar ataxia

Clinical trials30 trials listed for spinocerebellar ataxiaEvery trial the registry lists for spinocerebellar ataxia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in spinocerebellar ataxia researchLatest monthly update: September 2026. Includes: NBP trial result. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Dec 31, 2026 (estimated)
Primary completion: Jun 30, 2027 (estimated)
Study completion: Dec 31, 2027 (estimated)
Target enrollment: 45 participants (estimated)
Last updated on registry: Apr 23, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Sclnow Biotechnology Co., Ltd.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Lei Guo 📞 861064368977 ✉ georgeguo@sclnow.com

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
open label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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