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

NCT05698017 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: Cyt MSA hOMSC300
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Multiple System Atrophy; MSA - Multiple System Atrophy

Keywords

multiple system atrophy; MSA; stem cells; intrathecal

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment related serious adverse events (SAEs)

  18 months

• Number of participants with treatment related adverse events (AEs)

  18 months

Study Arms (2)

Low dose hOMSC300

EXPERIMENTAL

Single IT administration of low dose hOMSC300

Biological: hOMSC300

High dose hOMSC300

EXPERIMENTAL

Single IT administration of high dose hOMSC300

Biological: hOMSC300

Interventions

hOMSC300 BIOLOGICAL

Human Oral Mucosa Stem Cells

High dose hOMSC300; Low dose hOMSC300

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytora Ltd.: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Multiple System Atrophy; Shy-Drager Syndrome

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: November 7, 2022
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)