Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early- to Moderate Stage MSA
Multiple System Atrophy, MSA - Multiple System Atrophy
About this trial
This is an interventional treatment trial for Multiple System Atrophy focused on measuring multiple system atrophy, MSA, stem cells, intrathecal
Eligibility 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
Sites / Locations
- Tel-Aviv Sourasky Medical Center (Ichilov)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Other
Low dose hOMSC300
High dose hOMSC300
Sham Procedure
Single IT administration of low dose hOMSC300
Single IT administration of high dose hOMSC300
Lumbar puncture only