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

Sponsor

Cytora Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05698017

Collaborator

(none)

Enrollment

Location

Arms

39.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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) .

Condition or Disease	Intervention/Treatment	Phase
Multiple System Atrophy MSA - Multiple System Atrophy	Drug: hOMSC300 Other: Sham Procedure	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 7, 2022

Anticipated Primary Completion Date :

Feb 19, 2026

Anticipated Study Completion Date :

Feb 19, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Treatment related SAEs per dose group [18 months]
Treatment related adverse events per dose group [18 months]

Secondary Outcome Measures

Clinically significant motor and behavioral change from baseline [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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