Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-SA) for Patients With Spinocerebellar Ataxia
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ClinicalTrials.gov Identifier: NCT03378414 |
Recruitment Status :
Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : May 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6 | Procedure: Intravenous infusion Procedure: Intrathecal injection Biological: umbilical cord mesenchymal stem cell | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Research on the Safety/Efficacy of Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Spinocerebellar Ataxia |
Estimated Study Start Date : | June 2022 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Intravenous infusion group
Umbilical cord mesenchymal stem cells (SCLnow 19#)
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Procedure: Intravenous infusion
Intravenous infusion of mesenchymal stem cells: 2 * 10^7 cells (30ml) Biological: umbilical cord mesenchymal stem cell Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), the dosage based on different procedure |
Experimental: Intrathecal injection group
Umbilical cord mesenchymal stem cells (SCLnow 19#)
|
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 |
No Intervention: Control groups
No intervention
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- Scale for the assessment anf rating of ataxia (SARA) [ Time Frame: 12 months ]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.
- Image examinations [ Time Frame: 12 months ]MRI plain scan of brain.
- Inventory of Non-Ataxia Symptoms (INAS) score [ Time Frame: 12 months ]Using Inventory of Non-Ataxia Symptoms (INAS) score to determine the presence and severity of non-ataxia signs.
- Cerebrospinal fluid (csf) routine [ Time Frame: 12 months ]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.

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Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378414
Contact: Lei Guo | 861064368977 | georgeguo@sclnow.com |
Principal Investigator: | Hong Jiang | Xiangya Hospital of Central South University |
Responsible Party: | Sclnow Biotechnology Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03378414 |
Other Study ID Numbers: |
SCLnow-XY-03 |
First Posted: | December 19, 2017 Key Record Dates |
Last Update Posted: | May 9, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Spinocerebellar Ataxia,Mesenchymal Stem Cells |
Ataxia Cerebellar Ataxia Spinocerebellar Ataxias Spinocerebellar Degenerations Machado-Joseph Disease Dyskinesias Neurologic Manifestations Nervous System Diseases |
Cerebellar Diseases Brain Diseases Central Nervous System Diseases Spinal Cord Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn |