BioCells Medical
Warsaw, 02-797, Poland
NCT Number: NCT07467733
This clinical study aims to evaluate the safety and preliminary therapeutic potential of mesenchymal stem cell-derived therapies in patients diagnosed with spinocerebellar palsy. The investigational treatment includes neuroinduced mesenchymal stem cells and their derived exosomes administered via intravenous and intranasal infusion.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Phase 1 / Phase 2
Warsaw, 02-797, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinical diagnosis of spinocerebellar palsy confirmed by neurological examination; Disease duration ≤10 years; Ability to provide informed consent.
Exclusion criteria
Severe systemic illness; Active infection; History of malignancy within 5 years; Prior stem cell therapy; Pregnancy or breastfeeding.
200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.
Intranasal infusion of purified exosomes derived from mesenchymal stem cells
Time frame: 92 weeks
Change in motor symptoms measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Motor Examination Range: 0-132 Where 132 is the worst motor impairment; 0 - the best motor impairment
Time frame: 92 weeks
Change in motor function as measured by the Scale for the Assessment and Rating of Ataxia (SARA) Range: 0-40 40 - the most severe ataxia; 0 - the mildest
Time frame: 92 weeks
Change in neurological function measured by the International Cooperative Ataxia Rating Scale (ICARS) Range: 0-100 100 is the worst neurological impairment; 0 - the best
Contact information is provided by the study sponsor or research team.
Biocells Medical
Industry
Phase I/II Randomized Controlled Study Evaluating the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy
Acronym: NEURO-SCP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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