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Spinocerebellar Ataxia Type 1Phase 2NCT03378414

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

A Phase 2 study testing Intravenous infusion, Intrathecal injection and umbilical cord mesenchymal stem cell in people with Spinocerebellar Ataxia Type 1 and Spinocerebellar Ataxia Type 2, run by Sclnow Biotechnology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 60 years
What is being tested?
Intravenous infusion, Intrathecal injection and umbilical cord mesenchymal stem cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
31 Dec 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lei Guo contact

861064368977

georgeguo@sclnow.com

About this study

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

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.

Read the 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.

Being tested
Intravenous infusion, Intrathecal injection, umbilical cord mesenchymal stem cell
Keywords
Spinocerebellar Ataxia,Mesenchymal Stem Cells
Medical subject headings
Spinocerebellar Ataxias, Machado-Joseph Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous infusionProcedure or surgery

    Intravenous infusion of mesenchymal stem cells: 2 * 10^7 cells (30ml)

  • Intrathecal injectionProcedure or surgery

    Intrathecal injection of mesenchymal stem cells: 2 * 10^7 cells (1ml)

  • umbilical cord mesenchymal stem cellBiological

    Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), the dosage based on different procedure

Study groups in NCT03378414
Study groupRoleWhat they receive
Intravenous infusion groupExperimentalUmbilical cord mesenchymal stem cells (SCLnow 19#)
Receives: Procedure: Intravenous infusion; Biological: umbilical cord mesenchymal stem cell
Intrathecal injection groupExperimentalUmbilical cord mesenchymal stem cells (SCLnow 19#)
Receives: Procedure: Intrathecal injection; Biological: umbilical cord mesenchymal stem cell
Control groupsNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scale for the assessment anf rating of ataxia (SARA)

    Based on SARA score to calculate treatment efficacy. The equation is as follow, Efficacy = (patients who accepted treatment are effective/patients who accepted treatment)* 100% Effective: after 12 months, score of patient decrease 1 point or more; Ineffective: after 12 months, score decrease less than 1 point or increase.

    Measured: 12 months

Secondary outcomes (3)

  1. Image examinations

    MRI plain scan of brain.

    Measured: 12 months

  2. Inventory of Non-Ataxia Symptoms (INAS) score

    Using Inventory of Non-Ataxia Symptoms (INAS) score to determine the presence and severity of non-ataxia signs.

    Measured: 12 months

  3. Cerebrospinal fluid (csf) routine

    Patients is observed by professionals, compare the changes of each observation point and baseline. Baseline is the data acquire from patients before stem cells treatment.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378414
Sponsor's protocol ID
SCLnow-XY-03
Status last verified
Dec 2025
First submitted
12 Dec 2017
Last updated
23 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous infusion, Intrathecal injection and umbilical cord mesenchymal stem cell in people with Spinocerebellar Ataxia Type 1 and Spinocerebellar Ataxia Type 2, run by Sclnow Biotechnology Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Guo (861064368977, georgeguo@sclnow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scale for the assessment anf rating of ataxia (SARA) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03378414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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