NCT07471230

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
37mo left

Started Nov 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

November 23, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2029

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Parkinsonism or Parkinson's Disease NosParkinsonism in Diseases Classified Elsewhere

Keywords

mesenchymalexosomesparkinsonismstem cells

Outcome Measures

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

    48

Secondary Outcomes (1)

  • MDS-UPDRS

    48

Study Arms (3)

Neuroinduced Mesenchymal Stem Cells

EXPERIMENTAL

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

Biological: Intrathecal (IT)

Mesenchymal Stem Cell Derived Exosomes

EXPERIMENTAL

1×10¹¹ particles per infusion

Biological: Intravenous

Intravenous saline infusion

PLACEBO COMPARATOR
Biological: Intravenous

Interventions

Intrathecal (IT)BIOLOGICAL

Intrathecal injection of 3 ml between L4-L5

Neuroinduced Mesenchymal Stem Cells
IntravenousBIOLOGICAL

Intravenous injection via a drip

Intravenous saline infusionMesenchymal Stem Cell Derived Exosomes

Eligibility Criteria

Age48 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months

You may not qualify if:

  • Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuropostep

Warsaw, 02-797, Poland

Location

MeSH Terms

Conditions

Parkinsonian DisordersParkinson Disease

Interventions

Injections, Spinal

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Andrei Peskau

CONTACT

+48452365311info@biocellsmedical.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start (Estimated)

November 23, 2026

Primary Completion (Estimated)

November 23, 2028

Study Completion (Estimated)

November 23, 2029

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

PL(1)