A Phase 2 interventional study of Intravenous infusion and Intrathecal injection in Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2 and Spinocerebellar Ataxia Type 3, sponsored by Sclnow Biotechnology Co., Ltd.. Not yet recruiting. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Sclnow Biotechnology Co., Ltd. · Phase 2, Interventional, and Treatment
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.
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.
33 studies on the registry are indexed under Machado-Joseph Disease; 5 are open to participants now.
This study's planned enrollment of 45 is above the median of 23 across 21 interventional studies indexed under Machado-Joseph Disease.
Browse Machado-Joseph Disease studies →Sclnow Biotechnology Co., Ltd. is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
Compared within Machado-Joseph Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinocerebellar Ataxias. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Umbilical cord mesenchymal stem cells (SCLnow 19#)
Procedure: Intravenous infusion · Biological: umbilical cord mesenchymal stem cell
Umbilical cord mesenchymal stem cells (SCLnow 19#)
Procedure: Intrathecal injection · Biological: umbilical cord mesenchymal stem cell
No intervention
Intravenous infusion of mesenchymal stem cells: 2 \* 10\^7 cells (30ml)
Intrathecal injection of mesenchymal stem cells: 2 \* 10\^7 cells (1ml)
Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), the dosage based on different procedure
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
Image examinations
MRI plain scan of brain.
Time frame: 12 months
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
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
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Jun 2027, 5 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Sclnow Biotechnology Co., Ltd.