Status:
NOT_YET_RECRUITING
Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-SA) for Patients With Spinocerebellar Ataxia
Lead Sponsor:
Sclnow Biotechnology Co., Ltd.
Conditions:
Spinocerebellar Ataxia Type 1
Spinocerebellar Ataxia Type 2
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief 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 possi...
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 (incl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03378414
Start Date
December 31 2025
End Date
December 31 2026
Last Update
December 4 2025
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