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New treatment option for ALS
Official title Clinical Study of Induced Pluripotent Stem Cells Derived Motor Neuron Precursor Cell Therapy for Amyotrophic Lateral Sclerosis (ALS)
ClinicalTrials.gov ID: NCT06765564
What this study is testing
What is iPSC-MNP?
iPSC-MNP is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for als.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Amyotrophic lateral sclerosis (ALS) is a severe neurodegenerative disease in the human motor system characterized by the selective involvement of spinal cord anterior horn cells, brainstem motor nuclei, and the corticospinal tract. It predominantly presents as concurrent damage to upper and lower motor neurons.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Patients themselves or their legal guardians must consent to undergo this treatment protocol and sign the Informed Consent Form (ICF).
- Age between 18 and 60 years, inclusive, with no gender restrictions.
- Diagnosed with ALS according to the World Federation of Neurology criteria, and the initial diagnosis date is between 6 to 24 months before the...
- Patients who have received standard treatment in the past with poor how well it works or disease progression.
- Forced Vital Capacity (FVC) should be ≥50%.
You likely can't join if
- Patients with symptoms of neuromuscular weakness but cannot be conclusively determined to have ALS.
- Patients diagnosed with severe cognitive impairment, clinical dementia, or major psychiatric disorders, including but not limited to schizophrenia...
- Patients with any disease that impairs nerve or muscle function, such as peripheral neuropathy or metabolic myopathy.
- Patients with a history of malignant tumors or a previous diagnosis of malignancy.
- Within the two weeks preceding the screening period, patients who experienced acute active infections requiring treatment with antibiotics, antiviral...
- ALS patients with concomitant respiratory failure.
See the full eligibility criteria
- Patients themselves or their legal guardians must consent to undergo this treatment protocol and sign the Informed Consent Form (ICF).
- Age between 18 and 60 years, inclusive, with no gender restrictions.
- Diagnosed with ALS according to the World Federation of Neurology criteria, and the initial diagnosis date is between 6 to 24 months before the screening date.
- Patients who have received standard treatment in the past with poor how well it works or disease progression.
- Forced Vital Capacity (FVC) should be ≥50%.
- During any night of the screening period, the total time with peripheral blood oxygen saturation \<90% should not exceed 2%.
- Patients should be deemed by the investigator to be in good nutritional status, with a Body Mass Index (BMI) ≥18.5.
- Male patients and their spouses, as well as women of childbearing age, should agree to implement effective contraceptive measures from the time of signing the ICF until one year after the start of treatment.
- Patients should be able to cooperate in the collection and preservation of medical history data and the visit process.
- Patients with symptoms of neuromuscular weakness but cannot be conclusively determined to have ALS.
- Patients diagnosed with severe cognitive impairment, clinical dementia, or major psychiatric disorders, including but not limited to schizophrenia, bipolar disorder, or severe depression, according to the Diagnostic and...
- Patients with any disease that impairs nerve or muscle function, such as peripheral neuropathy or metabolic myopathy.
- Patients with a history of malignant tumors or a previous diagnosis of malignancy.
- Within the two weeks preceding the screening period, patients who experienced acute active infections requiring treatment with antibiotics, antiviral drugs, or antifungal medications.
- ALS patients with concomitant respiratory failure.
- Patients who have previously undergone any allogeneic cell therapy or organ transplantation.
- Patients who have Participated in other clinical trials within the three months prior to screening.
- Patients with a history of tracheostomy or those using mechanical ventilatory support.
- Patients with a documented history of severe allergic reactions to general anesthesia drugs or previous severe allergic reactions for other reasons.
- Patients with intracranial organic diseases causing increased intracranial pressure.
- Patients with elevated liver function test results during the screening period, such as total bilirubin \>1.5 times the upper limit of normal (ULN), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT)...
- Patients who have abnormal kidney function test results during the screening period, such as serum creatinine \>1.5 mg/dL or an estimated creatinine clearance rate \<60 mL/min calculated by the Cockcroft and Gault...
- Other clinically significant laboratory abnormalities during the screening period.
- Patients with hepatitis A, active hepatitis B (HBsAg positive and HBV DNA ≥500 IU/ml, excluding drug- or other-caused hepatitis), active hepatitis C (anti-HCV antibody positive and HCV RNA positive), hepatitis E, human...
- Patients with impaired consciousness.
- Coagulation abnormalities (prothrombin time [PT] or international normalized ratio [INR] \>1.5 times ULN; activated partial thromboplastin time [APTT] \>1.5 times ULN) or those currently receiving anticoagulation...
- Poorly controlled hypertension, with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg after treatment.
- Severe diabetes with late complications; patients with other diseases affecting limb mobility (e.g., limping, osteoarthritis, rheumatoid arthritis, gout, etc.).
- Patients who have undergone surgery or experienced trauma (including fractures) in the past month.
- Pregnant or breastfeeding women.
- Patients who, in the opinion of the investigator, have poorly controlled systemic diseases or other conditions that make them unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.