Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early- to Moderate Stage MSA

• Status: Recruiting
• Trial end date: 2026-02-19
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of this phase 1/2a study is to assess the safety and efficacy of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA) .

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytora Ltd.

Criteria

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