Clinical Trials Logo
  1. Home
  2. Tourette Syndrome
  3. NCT05158439
  4. Details
NCT05158439 Clinical Trial

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Tourette Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05158439
Other study ID # ATG-2-MSC-014
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 2022
Est. completion date January 2026

Study information
Verified date November 2021
Source The Foundation for Orthopaedics and Regenerative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 Tourette Syndrome

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 Tourette Syndrome. Patients will receive a single 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosis of Tourette Syndrome - 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations
Country Name City State
Antigua and Barbuda Medical Surgical Associates Center St. John's

Sponsors (1)
Lead Sponsor Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Country where clinical trial is conducted

Antigua and Barbuda, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (adverse events) Clinical monitoring of possible adverse events or complications Four year follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT04851678 - Longitudinal Impact of Stressors in Adults With Tourette Syndrome
Completed NCT02605902 - Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders N/A
Completed NCT04007913 - Incorporating teleCBIT Into a Hospital-Based Tic Program N/A
Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Completed NCT02256475 - Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Phase 1
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT01329198 - Brain Stimulation for the Treatment of Tourette Syndrome N/A
Terminated NCT00952601 - Pilot Study of the Modified Atkins Diet for Tourette Syndrome Phase 1
Enrolling by invitation NCT00355927 - Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. N/A
Completed NCT00206323 - A Randomized, Placebo-controlled, Tourette Syndrome Study. Phase 3
Completed NCT00004376 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Phase 3
Completed NCT04498364 - Extinction Learning in Adults With Tourette Syndrome N/A
Completed NCT00755339 - Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
Completed NCT03325010 - Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Completed NCT01719523 - Open-Trial of EPI-743 for Adults With Tourette Syndrome Phase 1
Completed NCT01702077 - Neurofeedback for Tourette Syndrome N/A
Completed NCT00231985 - Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Phase 2
Completed NCT00206336 - An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Phase 3
Terminated NCT03732534 - Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome Phase 2