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Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy

Primary Purpose

Peripheral Neuropathy, Trigeminal Neuralgia

Status

Recruiting

Phase

Phase 1

Locations

Antigua and Barbuda

Study Type

Interventional

Intervention

AlloRx

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Peripheral Neuropathy, Trigeminal Neuralgia, stem cell treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy
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

Sites / Locations

Medical Surgical Associates CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group (AlloRx)

Arm Description

Single intravenous infusion of 100 million cells

Outcomes

Primary Outcome Measures

Safety (adverse events)

Clinical monitoring of possible adverse events or complications

Secondary Outcome Measures

Full Information

NCT ID

NCT05152368

First Posted

November 29, 2021

Last Updated

October 25, 2022

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05152368

Brief Title

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy

Official Title

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Trigeminal Neuralgia and Peripheral Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 9, 2022 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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 Trigeminal Neuralgia and Peripheral Neuropathy

Detailed Description

This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Trigeminal Neuralgia and Peripheral Neuropathy. Patients will receive intravenous infusion of UC-MSCs. The total dose 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 an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy, Trigeminal Neuralgia

Keywords

Peripheral Neuropathy, Trigeminal Neuralgia, stem cell treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group (AlloRx)

Arm Type

Experimental

Arm Description

Single intravenous infusion of 100 million cells

Intervention Type

Biological

Intervention Name(s)

AlloRx

Intervention Description

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Primary Outcome Measure Information:

Title

Safety (adverse events)

Description

Clinical monitoring of possible adverse events or complications

Time Frame

Four year follow-up

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chadwick Prodromos, MD

Organizational Affiliation

The Foundation for Orthopaedics and Regenerative Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Surgical Associates Center

City

St. John's

Country

Antigua and Barbuda

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chadwick Prodromos, M.D.

Phone

8476996810

care@thepsci.com

12. IPD Sharing Statement

Learn more about this trial

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy

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