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

Last updated: January 26, 2025
Sponsor: Cytora Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Multiple System Atrophy

Treatment

hOMSC300

Clinical Study ID

NCT05698017
Cyt MSA hOMSC300
  • Ages 50-80
  • All Genders

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 Criteria

Inclusion

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 theability 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'sclinical judgement, and MoCA >= 24

Exclusion

Exclusion Criteria:

  • Pregnant women and women before menopause

  • Participants with a clinically significant or unstable medical or surgical conditionthat, in the opinion of the investigator, might preclude safe completion of thetreatment or affect the treatment outcome.

  • Patients with thrombocytopenia, other bleeding diathesis or taking anticoagulanttherapy (not including Aspirin up to 100mg per day)

  • Patients with known hypersensitivities to Plasmalyte, Gadolinium, Penicillin, andwith general hypersensitivity to antibiotics

  • Patients who fulfill the criteria of Parkinson's Disease

  • History of electroconvulsive therapy

  • History of brain surgery

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: hOMSC300
Phase: 1
Study Start date:
November 07, 2022
Estimated Completion Date:
February 19, 2026

Connect with a study center

  • Tel-Aviv Sourasky Medical Center (Ichilov)

    Tel Aviv,
    Israel

    Site Not Available

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