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

Cytora

Status and phase

Active, not recruiting

Phase 1

Conditions

Multiple System Atrophy

MSA - Multiple System Atrophy

Treatments

Biological: hOMSC300

Study type

Interventional

Funder types

Industry

Identifiers

NCT05698017

Cyt MSA hOMSC300

Details and patient eligibility

About

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)

Enrollment

10 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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