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

Launched by SCLNOW BIOTECHNOLOGY CO., LTD. · Dec 18, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for patients with Spinocerebellar Ataxia (SCA), which is a group of genetic disorders that affect movement and coordination. The goal is to see if this therapy can be safe and effective for improving the symptoms of patients with different types of SCA, specifically types 1, 2, 3, and 6. Researchers also want to understand how this treatment works in the body.

To participate, individuals aged between 58 and 94 years old who have been diagnosed with one of the SCA types mentioned and have a specific score on a movement assessment may be eligible. Participants should not have received any stem cell treatments in the last six months and need to provide their consent to join the study. It’s important to note that people with certain health issues, severe allergies, or those who are pregnant or breastfeeding cannot take part in this trial. If you qualify, you can expect to receive the therapy and be monitored closely by healthcare professionals throughout the study. This trial is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• 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