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

Phase 1

Active, not recruiting

• Conditions: Multiple System Atrophy; MSA - Multiple System Atrophy
• Interventions: Biological: hOMSC300

• Registration Number: NCT05698017
• Lead Sponsor: Cytora Ltd.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-02-19
• Study Completion: 2026-02-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low dose hOMSC300	hOMSC300	Single IT administration of low dose hOMSC300
High dose hOMSC300	hOMSC300	Single IT administration of high dose hOMSC300

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center (Ichilov); 🇮🇱 Tel Aviv, Israel