Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy
NEURO-SCP
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
1 other identifier
interventional
90
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
March 12, 2026
March 1, 2026
2 years
March 9, 2026
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
MDS-UPDRS
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
92 weeks
SARA
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
92 weeks
Secondary Outcomes (1)
ICARS
92 weeks
Study Arms (3)
Neuroinduced Mesenchymal Stem Cells
EXPERIMENTALMesenchymal Stem Cell Derived Exosomes
EXPERIMENTALSaline solution
PLACEBO COMPARATORInterventions
200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.
Intranasal infusion of purified exosomes derived from mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of spinocerebellar palsy confirmed by neurological examination; Disease duration ≤10 years; Ability to provide informed consent.
You may not qualify if:
- Severe systemic illness; Active infection; History of malignancy within 5 years; Prior stem cell therapy; Pregnancy or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocells Medicallead
Study Sites (1)
BioCells Medical
Warsaw, 02-797, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Biocells Medical
Study Record Dates
First Submitted
March 9, 2026
First Posted
March 12, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share