Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis

Study Purpose:

This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of amyotrophic lateral sclerosis

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:





Phase 1

Study Chair(s)/Principal Investigator(s):

Chadwick Prodromos, MD, The Foundation for Orthopaedics and Regenerative Medicine ID:


Neals Affiliated?


Coordinating Center Contact Information

Full Study Summary:

Amyotrophic lateral sclerosis is a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and can improve the prognosis of afflicted patients. Patients with ALS will receive three intrathecal injections of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for each injection will be 50 million cells and the injections will be at two-month intervals. 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.

Study Sponsor:

The Foundation for Orthopaedics and Regenerative Medicine

Estimated Enrollment:


Estimated Study Start Date:

12 / 01 / 2022

Estimated Study Completion Date:

09 / 01 / 2025

Posting Last Modified Date:

10 / 07 / 2022

Date Study Added to

08 / 13 / 2021

Minimum Age:


Maximum Age:


Inclusion Criteria:

- Diagnosis of Amyotrophic Lateral Sclerosis.

- Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

- Active infection

- Active cancer

- Chronic multisystem organ failure

- Pregnancy

- Anticoagulation medicine use

- Clinically significant Abnormalities on pre-treatment laboratory evaluation

- Medical condition that would (based on the opinion of the investigator) compromise patient's safety.

- Previous organ transplant

- Hypersensitivity to sulfur

- Continued drug abuse

- Pre-menopausal women not using contraception

Medical Surgical Associates Center

St. John's
Antigua and Barbuda