Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis
| Verified date | October 2022 |
| Source | The Foundation for Orthopaedics and Regenerative Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Suspended |
| Enrollment | 20 |
| Est. completion date | September 2025 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Antigua and Barbuda | Medical Surgical Associates Center | St. John's |
| Lead Sponsor | Collaborator |
|---|---|
| The Foundation for Orthopaedics and Regenerative Medicine |
Antigua and Barbuda,
Barczewska M, Maksymowicz S, Zdolinska-Malinowska I, Siwek T, Grudniak M. Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis: an Original Study. Stem Cell Rev Rep. 2020 Oct;16(5):922-932. doi: 10.1007/s12015-020-10016-7. — View Citation
Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. — View Citation
Oh KW, Noh MY, Kwon MS, Kim HY, Oh SI, Park J, Kim HJ, Ki CS, Kim SH. Repeated Intrathecal Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis. Ann Neurol. 2018 Sep;84(3):361-373. doi: 10.1002/ana.25302. Epub 2018 Aug 31. — View Citation
Petrou P, Gothelf Y, Argov Z, Gotkine M, Levy YS, Kassis I, Vaknin-Dembinsky A, Ben-Hur T, Offen D, Abramsky O, Melamed E, Karussis D. Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis: Results of Phase 1/2 and 2a Clinical Trials. JAMA Neurol. 2016 Mar;73(3):337-44. doi: 10.1001/jamaneurol.2015.4321. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | |
| Secondary | Efficacy: revised ALS functional rating scale (ALSFRS-R) | ALSFRS-R scale is used to evaluate the progression of disability in patients with ALS. It will be completed for each follow up point. | Four year follow-up |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04428775 -
A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease
|
Phase 2 | |
| Recruiting |
NCT04998305 -
TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05951556 -
Telehealth Implementation of Brain-Computer Interface
|
N/A | |
| Terminated |
NCT04579666 -
MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Recruiting |
NCT04082832 -
CuATSM Compared With Placebo for Treatment of ALS/MND
|
Phase 2/Phase 3 | |
| Completed |
NCT01925196 -
Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
|
||
| Completed |
NCT02496767 -
Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year
|
Phase 3 | |
| Recruiting |
NCT04816227 -
Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
|
||
| Active, not recruiting |
NCT04494256 -
A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
|
Phase 1/Phase 2 | |
| Completed |
NCT03706391 -
Study of ALS Reversals 4: LifeTime Exposures
|
||
| Recruiting |
NCT04882904 -
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
|
N/A | |
| Completed |
NCT04557410 -
Open Label Study: Treatment of ALS Fatigue With PolyMVA
|
Phase 1 | |
| Active, not recruiting |
NCT04948645 -
A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis
|
Phase 1 | |
| Not yet recruiting |
NCT04089696 -
Validation of the "ExSpiron©" in Patients With ALS
|
N/A | |
| Not yet recruiting |
NCT05860244 -
Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients
|
Phase 2 | |
| Recruiting |
NCT02917681 -
Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03067857 -
Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02874209 -
Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis
|
N/A | |
| Active, not recruiting |
NCT02567136 -
Imaging Biomarkers in ALS
|
||
| Completed |
NCT02059759 -
Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2
|
Phase 2 |