Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS

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

Status

Suspended

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05003921

Enrollment

Registered

2021-08-13

Start date

2025-12-31

Completion date

2028-09-30

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, ALS, Stem cells

Brief summary

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

Detailed description

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.

Interventions

BIOLOGICALAlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Secondary

Measure	Time frame	Description
Efficacy: revised ALS functional rating scale (ALSFRS-R)	Four year follow-up	ALSFRS-R scale is used to evaluate the progression of disability in patients with ALS. It will be completed for each follow up point.

Countries

Antigua and Barbuda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026