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Clinical Trials in Israel / NCT05698017
Active, not recruiting Phase 1

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

NCT05698017 · tracked via the Priya Life Science Israel tracker
Sponsor
Cytora Ltd
Phase
Phase 1
Started
2022-11-07
Last updated
2025-01-29

Condition(s) studied

Multiple System AtrophyMSA - Multiple System Atrophy

Investigational drug(s) / intervention(s)

hOMSC300

hOMSC300: Human Oral Mucosa Stem Cells

Study 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)

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tel-Aviv Sourasky Medical Center (Ichilov) Tel Aviv Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05698017 on ClinicalTrials.gov ↗ ← All trials in Israel