A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells

NCT ID: NCT06163508

Last Updated: 2025-04-03

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

ENROLLING_BY_INVITATION

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-12

Study Completion Date

2035-12-31

Brief Summary

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This study is an observational study designed to obtain information on the long-term safety, tolerability, and continued activity of Q-Cells®. The study will follow the participants who previously received Q-Cells® for 10 years.

The goal of this observational study is to learn about the long term effects of Q-Cells® in people with transverse myelitis.

The main objectives the study is to evaluate the safety of patients who have received Q-Cells®.

The secondary goal of the study is to get data about the long-term activity of Q-Cells® over a period of 10 years.

Patients will complete exams, lab tests, imaging, and questionnaires to monitor their safety.

Detailed Description

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Conditions

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Transverse Myelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: 10 microliters of Q cells

10 microliters of Q cells per site

Q-Cells®

Intervention Type DRUG

Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.

Cohort 2: 15 microliters of Q cells

15 microliters of Q cells per site

Q-Cells®

Intervention Type DRUG

Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.

Cohort 3: 20 microliters of Q cells

20 microliters of Q cells per site

Q-Cells®

Intervention Type DRUG

Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.

Interventions

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Q-Cells®

Long term observational study of patients who received 1 of 3 different amounts of Q-Cells®.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects must have been administered Q-Cells® as part of Protocol QTM-101 or other treatment Protocol.
2. Subjects must have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations.

Exclusion Criteria

1\. The study is intended to follow all subjects who have received Q-Cells® without exception.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Greenberg

Benjamin M. Greenberg, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Greenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medial Center

Locations

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The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2023-0803

Identifier Type: -

Identifier Source: org_study_id

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