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

Primary Purpose

Multiple System Atrophy, MSA - Multiple System Atrophy

Status
Recruiting
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
hOMSC300
Sham Procedure
Sponsored by
Cytora Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy focused on measuring multiple system atrophy, MSA, stem cells, intrathecal

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tel-Aviv Sourasky Medical Center (Ichilov)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Low dose hOMSC300

High dose hOMSC300

Sham Procedure

Arm Description

Single IT administration of low dose hOMSC300

Single IT administration of high dose hOMSC300

Lumbar puncture only

Outcomes

Primary Outcome Measures

Treatment related SAEs per dose group
Treatment related adverse events per dose group

Secondary Outcome Measures

Clinically significant motor and behavioral change from baseline

Full Information

First Posted
January 16, 2023
Last Updated
January 24, 2023
Sponsor
Cytora Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05698017
Brief Title
Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early- to Moderate Stage MSA
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
February 19, 2026 (Anticipated)
Study Completion Date
February 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytora Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy, MSA - Multiple System Atrophy
Keywords
multiple system atrophy, MSA, stem cells, intrathecal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be allocated to one of the following arms: Low dose single intrathecal (IT) administration of hOMSC300 High dose single intrathecal (IT) administration of hOMSC300 Sham procedure (control)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose hOMSC300
Arm Type
Active Comparator
Arm Description
Single IT administration of low dose hOMSC300
Arm Title
High dose hOMSC300
Arm Type
Active Comparator
Arm Description
Single IT administration of high dose hOMSC300
Arm Title
Sham Procedure
Arm Type
Other
Arm Description
Lumbar puncture only
Intervention Type
Drug
Intervention Name(s)
hOMSC300
Intervention Description
Human Oral Mucosa Stem Cells
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
Lumbar Puncture Only
Primary Outcome Measure Information:
Title
Treatment related SAEs per dose group
Time Frame
18 months
Title
Treatment related adverse events per dose group
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Clinically significant motor and behavioral change from baseline
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center (Ichilov)
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adi Ezra, MHA
Phone
972-52-4266940
Email
adil@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Vered Livneh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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