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

January 24, 2023 updated by: Cytora Ltd.

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

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) .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel-Aviv Sourasky Medical Center (Ichilov)
        • Contact:
        • Principal Investigator:
          • Vered Livneh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose hOMSC300
Single IT administration of low dose hOMSC300
Drug: hOMSC300
Human Oral Mucosa Stem Cells
Active Comparator: High dose hOMSC300
Single IT administration of high dose hOMSC300
Drug: hOMSC300
Human Oral Mucosa Stem Cells
Other: Sham Procedure
Lumbar puncture only
Other: Sham Procedure
Lumbar Puncture Only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment related SAEs per dose group
Time Frame: 18 months
18 months
Treatment related adverse events per dose group
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinically significant motor and behavioral change from baseline
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytora Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Anticipated)

February 19, 2026

Study Completion (Anticipated)

February 19, 2026

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cyt MSA hOMSC300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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