Clinical Trials Logo
  1. Home
  2. Peripheral Neuropathy
  3. NCT05152368
  4. Details
NCT05152368 Clinical Trial

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

Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05152368
Other study ID # ATG-1-MSC-019
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 9, 2022
Est. completion date January 2026

Study information
Verified date October 2022
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 Trigeminal Neuralgia and Peripheral Neuropathy

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
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 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

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
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Completed NCT02549534 - Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer N/A
Active, not recruiting NCT02701075 - MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain N/A
Completed NCT01196442 - Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer N/A
Completed NCT00763087 - Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet N/A
Completed NCT00079807 - Painful HIV Neuropathy and Alpha-Lipoic Acid Phase 1/Phase 2
Completed NCT03292328 - Yoga for Symptoms of Nerve Damage Caused by Chemotherapy N/A
Active, not recruiting NCT05379140 - Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV N/A
Recruiting NCT05673746 - Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer N/A
Completed NCT05189535 - "Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients" Phase 2/Phase 3
Recruiting NCT06219590 - Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy N/A
Enrolling by invitation NCT05595109 - Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients Phase 2/Phase 3
Completed NCT05916118 - Exercise and Oxaliplatin-induced Peripheral Neuropathy N/A
Withdrawn NCT03881748 - Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy N/A
Not yet recruiting NCT03112057 - Visualize Nociceptor Changes in Neuropathic Human N/A
Completed NCT02936843 - Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy Phase 2/Phase 3
Terminated NCT01458015 - Tapentadol Versus Oxycodon - a Mechanism-based Treatment Approach in Neuropathic Pain Phase 4
Completed NCT01006408 - Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy N/A
Completed NCT00471445 - Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients Phase 3
Completed NCT00380965 - Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy Phase 4