Evaluation of Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age48-70
SponsorBiocells Medical

About this trial

This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.

The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal (IT)

    Biological/Vaccine

    Intrathecal injection of 3 ml between L4-L5

  • Intravenous

    Biological/Vaccine

    Intravenous injection via a drip

Treatment groups

120 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: Intravenous saline infusionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

NMSS

Change in non-motor symptoms measured by the Non-Motor Symptoms Scale (NMSS) Range: 0-360 360 indicates the greatest symptom burden, 0 - the least

Time frame
48

Secondary 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 and 0 is the best

Time frame
48

Other outcomes

Sponsors and contacts

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

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