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Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy

ConditionSpinocerebellar Ataxia - All Sub-types
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBiocells Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal infusion

    Drug

    200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.

  • Intranasal infusion

    Drug

    Intranasal infusion of purified exosomes derived from mesenchymal stem cells

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Neuroinduced Mesenchymal Stem CellsExperimental treatment 1 intervention
Group B: Mesenchymal Stem Cell Derived ExosomesExperimental treatment 1 intervention
Group C: Saline solutionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
92 weeks
2

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

Time frame
92 weeks

Secondary outcomes

1

ICARS

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

Time frame
92 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biocells Medical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: