臨床研究等提出・公開システム

Safety and Efficacy of Intravenous Administeration of SHED-CM for ALS

Safety and Efficacy of Intravenous Administeration of SHED-CM for ALS

Seta Yasuhiro

Hitonowa Medical

K.PLAZA 2F 1-7 Rokubancho, Chiyoda-ku, Tokyo

info@u-factor-hitonowa.com

Sekine Midori

Hitonowa Medical

K.PLAZA 2F 1-7 Rokubancho, Chiyoda-ku, Tokyo

+81-3-6272-8181

info@u-factor-hitonowa.com

Recruiting

Mar. 25, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who meet the following inclusion criteria (1) to (6) at the time of Informed consent

(1) Patients who have provided written informed consent to participate in the study.
(2) Patients who are at least 20 years of age at the time of obtaining informed consent.
(3) Patients diagnosed with isolated or familial ALS and diagnosed as definite, the probable, or the probable laboratory-supported by updated Awaji criteria.
(4) Patients with severity 1 or 2 on ALS severity criteria.
(5) Outpatients.
(6) Patients residing in Japan who can communicate in Japanese.

Exclusion Criteria: Patients who do not meet any of the exclusion criteria (1) to (15) at the time of Informed consent

(1) Patients with a tracheostomy
(2) Patients with a history of non-invasive respiratory support
(3) Patients with a percent FVC of 60 or less
(4) Patients with chronic obstructive pulmonary disease (COPD)
(5) Patients newly treated with edaravone or riluzole (oral) within 4 weeks prior to Informed consent
(6) Patients newly received HAL medical leg type treatment, newly treated with mecobalamin within 4 weeks prior to Informed consent
(7) Patients receiving intravenous edaravone
(8) Patients with cognitive impairment
(9) Pregnant women or patients who may be pregnant
(10) Patients with serious respiratory, cardiovascular, hepatic, or renal disease
(11) Patients with malignant tumors
(12) Patients with uncontrolled infection
(13) Patients who have participated in other clinical trials within 12 weeks prior to obtaining consent
(14) Patients with a history of drug allergy or severe allergic disease (e.g., anaphylactic shock) or concomitant history
(15) Patients who are deemed inappropriate to participate in the study by the principal investigator or research coordinator.

Both

amyotrophic lateral sclerosis (ALS)

The study drug will be administered intravenously once weekly from the first day of administration until Week 12 of the treatment period.

ALS

8B60.0

Safety assessment during the study period: Adverse events
Laboratory tests
Vital signs
Self- and other findings

Efficacy assessment: ALSFRS-R, %FVC, grip strength

+81-3-5542-1597

Jan. 25, 2024

none