Health TrialsbyHealthPanel

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

ConditionsSpinocerebellar Ataxia Type 1Spinocerebellar Ataxia Type 2Spinocerebellar Ataxia Type 3Spinocerebellar Ataxia Type 6
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-60
SponsorSclnow Biotechnology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous infusion

    Procedure/Surgery

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

  • Intrathecal injection

    Procedure/Surgery

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

  • umbilical cord mesenchymal stem cell

    Biological/Vaccine

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

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Intravenous infusion groupExperimental treatment 2 interventions
Group B: Intrathecal injection groupExperimental treatment 2 interventions
Group C: Control groupsNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame
12 months

Secondary outcomes

1

Image examinations

MRI plain scan of brain.

Time frame
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.

Time frame
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.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sclnow Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: