Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early to Moderate Stage Multiple System Atrophy (MSA)

Phase 1 Open-Label Study for Treatment of Early to Moderate Stage Multiple System Atrophy Patients With the Investigational Allogeneic Cell Therapy Product, hOMSC300

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05698017

Enrollment

Registered

2023-01-26

Start date

2022-11-07

Completion date

2026-02-19

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MSA - Multiple System Atrophy, Multiple System Atrophy

Keywords

multiple system atrophy, MSA, stem cells, intrathecal

Brief summary

Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA)

Interventions

BIOLOGICALhOMSC300

Human Oral Mucosa Stem Cells

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Patients will be allocated to one of the following arms: 1. The first 2 subjects recruited will be treated with the Low dose single Intrathecal (IT) administration of hOMSC300 2. The following 2 subjects recruited will be treated with the High dose single intrathecal (IT) administration of hOMSC300; In the absence of any treatment related SAEs, the remaining patients (6) will be treated with the high dose, without further staggering.

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patient was diagnosed with probable MSA-C (cerebellar) or MSA-P (parkinsonian) variant within 60 months of symptom onset (excluding impotence) * Subject can ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices is allowed * Patient cognitive state permits him to sign informed consent, according to the PI's clinical judgement, and MoCA \>= 24

Exclusion criteria

* Pregnant women and women before menopause * Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the treatment or affect the treatment outcome. * Patients with thrombocytopenia, other bleeding diathesis or taking anticoagulant therapy (not including Aspirin up to 100mg per day) * Patients with known hypersensitivities to Plasmalyte, Gadolinium, Penicillin, and with general hypersensitivity to antibiotics * Patients who fulfill the criteria of Parkinson's Disease * History of electroconvulsive therapy * History of brain surgery

Design outcomes

Primary

Measure	Time frame
Number of participants with treatment related serious adverse events (SAEs)	18 months
Number of participants with treatment related adverse events (AEs)	18 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026