Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for MS

NCT ID: NCT05003388

Last Updated: 2025-04-08

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-26

Study Completion Date

2025-10-31

Brief Summary

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This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of multiple sclerosis

Detailed Description

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Multiple Sclerosis (MS) can be a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and efficacious for the treatment of MS. Patients with MS will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Single intravenous infusion of 100 million cells

Group Type EXPERIMENTAL

AlloRx

Intervention Type BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Interventions

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AlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Multiple Sclerosis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Foundation for Orthopaedics and Regenerative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chadwick Prodromos, MD

Role: PRINCIPAL_INVESTIGATOR

The Foundation for Orthopaedics and Regenerative Medicine

Locations

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Medical Surgical Associates Center

St John's, , Antigua and Barbuda

Site Status RECRUITING

Athens Beverly Hills Medical Group

Glyfada, Athens, Greece

Site Status RECRUITING

Countries

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Antigua and Barbuda Greece

Facility Contacts

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Chadwick Prodromos, M.D.

Role: primary

8476996810

Chadwick Prodromos, MD

Role: primary

8476996810

References

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Meyer-Moock S, Feng YS, Maeurer M, Dippel FW, Kohlmann T. Systematic literature review and validity evaluation of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. BMC Neurol. 2014 Mar 25;14:58. doi: 10.1186/1471-2377-14-58.

Reference Type BACKGROUND
PMID: 24666846 (View on PubMed)

Petrou P, Kassis I, Levin N, Paul F, Backner Y, Benoliel T, Oertel FC, Scheel M, Hallimi M, Yaghmour N, Hur TB, Ginzberg A, Levy Y, Abramsky O, Karussis D. Beneficial effects of autologous mesenchymal stem cell transplantation in active progressive multiple sclerosis. Brain. 2020 Dec 1;143(12):3574-3588. doi: 10.1093/brain/awaa333.

Reference Type BACKGROUND
PMID: 33253391 (View on PubMed)

Riordan NH, Morales I, Fernandez G, Allen N, Fearnot NE, Leckrone ME, Markovich DJ, Mansfield D, Avila D, Patel AN, Kesari S, Paz Rodriguez J. Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis. J Transl Med. 2018 Mar 9;16(1):57. doi: 10.1186/s12967-018-1433-7.

Reference Type BACKGROUND
PMID: 29523171 (View on PubMed)

Li JF, Zhang DJ, Geng T, Chen L, Huang H, Yin HL, Zhang YZ, Lou JY, Cao B, Wang YL. The potential of human umbilical cord-derived mesenchymal stem cells as a novel cellular therapy for multiple sclerosis. Cell Transplant. 2014;23 Suppl 1:S113-22. doi: 10.3727/096368914X685005. Epub 2014 Nov 5.

Reference Type BACKGROUND
PMID: 25385295 (View on PubMed)

Other Identifiers

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SC-8-ATG-9-03

Identifier Type: -

Identifier Source: org_study_id

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