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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2026-02-19

Brief Summary

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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)

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WITHDRAWN

Detailed Description

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Conditions

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Multiple System Atrophy MSA - Multiple System Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Patients will be allocated to one of the following arms:

1. The first 2 subjects recruited will be treated with the Low dose single Intrathecal (IT) administration of hOMSC300
2. The following 2 subjects recruited will be treated with the High dose single intrathecal (IT) administration of hOMSC300; In the absence of any treatment related SAEs, the remaining patients (6) will be treated with the high dose, without further staggering.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose hOMSC300

Single IT administration of low dose hOMSC300

Group Type EXPERIMENTAL

hOMSC300

Intervention Type BIOLOGICAL

Human Oral Mucosa Stem Cells

High dose hOMSC300

Single IT administration of high dose hOMSC300

Group Type EXPERIMENTAL

hOMSC300

Intervention Type BIOLOGICAL

Human Oral Mucosa Stem Cells

Interventions

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hOMSC300

Human Oral Mucosa Stem Cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No