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| Name | Class |
|---|---|
| U-Factor Co.,Ltd. | UNKNOWN |
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This study evaluates the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media (SHED-CM) in patients with Amyotrophic Lateral Sclerosis (ALS), using the Japanese version of the revised ALS Functional Rating Scale (ALSFRS-R) as an indicator.
The main objective of this study is to evaluate the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media in patients with Amyotrophic Lateral Sclerosis (ALS), Particular focus will be placed on improving neurological function, slowing the rate of symptom progression, and improving the patient's quality of life.
What are the advantages of this therapy over standard therapy? and for which patients it is most effective ?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving the study drug | Experimental | The study drug will be administered intravenously at 120 ml once a week for 12 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The study drug is SHED-CM manufactured by U-Factor | Biological | This study will involve informed consent, a 12-week observation period, a 12-week study drug administration period, and a 4-week follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| All Adverse Events | This measure will check the total number of adverse events (AEs) reported during the study, categorized by CTCAE Ver 5.0 . | Immediately after each administration and up to 4 weeks post-treatment |
| Number of Clinically Significant Changes in Laboratory Test Results | This measure will track the number of events where clinically significant abnormalities are detected in laboratory test parameters, including blood count, biochemistry, and coagulation function tests. Changes from baseline to follow-up are evaluated based on predefined clinical thresholds. | Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16). |
| Number of Clinically Significant Changes in Vital Signs | This measure will evaluate the number of events where clinically significant changes in vital signs occur. Parameters include systolic blood pressure, diastolic blood pressure, pulse rate, body temperature, and SpO2. Each event will be assessed at two time points: immediately after treatment and after follow-up session, comparing values to baseline. | Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16). |
| Safety assessment during the study period: Adverse events - Self- and other findings | Medical examination, subjective findings, Other findings | Immediately after each administration and up to 4 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy assessment: ALSFRS-R | The revised ALS Functional Rating Scale in ALS Patients. This scale is scored from 0 to 48, the higher the score the better. | Change from baseline ALSFRS-R at follow-up session |
| Efficacy assessment: %FVC |
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Inclusion Criteria:
Patients who meet the following inclusion criteria (1) to (6) at the time of Informed consent
Exclusion Criteria:
Patients who do not meet any of the exclusion criteria (1) to (15) at the time of Informed consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hitonowa Medical | Chiyoda City | Tokyo | 102-0085 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35532908 | Result | Oki R, Izumi Y, Fujita K, Miyamoto R, Nodera H, Sato Y, Sakaguchi S, Nokihara H, Kanai K, Tsunemi T, Hattori N, Hatanaka Y, Sonoo M, Atsuta N, Sobue G, Shimizu T, Shibuya K, Ikeda K, Kano O, Nishinaka K, Kojima Y, Oda M, Komai K, Kikuchi H, Kohara N, Urushitani M, Nakayama Y, Ito H, Nagai M, Nishiyama K, Kuzume D, Shimohama S, Shimohata T, Abe K, Ishihara T, Onodera O, Isose S, Araki N, Morita M, Noda K, Toda T, Maruyama H, Furuya H, Teramukai S, Kagimura T, Noma K, Yanagawa H, Kuwabara S, Kaji R; Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS (JETALS) Collaborators. Efficacy and Safety of Ultrahigh-Dose Methylcobalamin in Early-Stage Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2022 Jun 1;79(6):575-583. doi: 10.1001/jamaneurol.2022.0901. |
| Label | URL |
|---|---|
| We referenced this paper because of the Phase III trial in ALS. | View source |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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A group of ALS patients receiving the study drug
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% forced vital capacity in ALS Patients
| Change from baseline %FVC at follow-up session |
| Efficacy assessment: grip strength | grip strength in ALS Patients | Change from baseline grip strength at follow-up session |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |