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)
Number of participants with treatment related serious adverse events (SAEs) — 18 months
Number of participants with treatment related adverse events (AEs) — 18 months
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.
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