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ALS Clinical Trials
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS
ALS Clinical Trials
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS
Quick Info
Status
Suspended due to COVID-19
Phase
1
Trial Type
Interventional
Treatment Type
Stem Cells
Randomization
None
Enrollment
20
Start Date
12/1/2022
(anticipated)
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Contact Information
Contact information unknown.
Locations
Antigua and Barbuda, Other
Medical Surgical Associates Center, St. John's, Antigua and Barbuda
Enrollment Criteria
Breathing Ability
Percent lung function (
FVC
) or (
SVC
)
N/A
Months Since Onset
Number of months since first symptoms of ALS.
N/A
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Yes
Diaphragm Pacer (DPS)
Can PALS use a
DPS
in the trial?
Yes
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Yes
Update Notes
Trial suspended
10/7/2022
Study start, contact updates
1/5/2022
Other Information
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
Eligibility
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
Details
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.
Collaborator(s)
The Foundation for Orthopaedics and Regenerative Medicine
Trial Protocol as Published on Clinicaltrials.gov
NCT05003921
(First Published: 8/6/2021)
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