Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early- to Moderate Stage MSA

Multiple System Atrophy Clinical Trial

Official title:

Phase 1/2a Randomized Controlled Study for Treatment of Early- to Moderate Stage Multiple System Atrophy Patients With the Investigational Allogeneic Cell Therapy Product, hOMSC300

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698017
• Other study ID #: Cyt MSA hOMSC300
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 7, 2022
• Est. completion date: February 19, 2026

Study information

• Verified date: January 2023
• Source: Cytora Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: February 19, 2026
• Est. primary completion date: February 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• MSA - Multiple System Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Drug:
• hOMSC300
Human Oral Mucosa Stem Cells

Other:
• Sham Procedure
Lumbar Puncture Only

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center (Ichilov)	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Cytora Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related SAEs per dose group		18 months
Primary	Treatment related adverse events per dose group		18 months
Secondary	Clinically significant motor and behavioral change from baseline		18 months