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NCT05698017
Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early- to Moderate Stage MSA
Conditions: Multiple System Atrophy, MSA - Multiple System Atrophy
Sex: All
Ages: 50 Years – 80 Years
Phase: PHASE1, PHASE2
Enrollment: 18
Sponsor: Cytora Ltd.
Location: Israel
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) .
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 allowedPatient cognitive state permits him to sign informed consent, according to the PI's clinical judgement, and MoCA >= 24Exclusion Criteria:Pregnant women and women before menopauseParticipants 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 antibioticsPatients who fulfill the criteria of Parkinson's DiseaseHistory of electroconvulsive therapyHistory of brain surgery
Source: ClinicalTrials.gov (NCT05698017). StuddyBuddy aggregates publicly available trial information.