STEMALS-II

Phase 1

• Conditions: Amyotrophic lateral sclerosis (ALS) is a severe progressive neurological disorder characterized by a selective degeneration of spinal, bulbar, and cortical motor neurons.; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-002228-28-IT
• Lead Sponsor: niversità degli Studi di Torino e Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-12
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

a. patients with definite, probable, probable laboratory-supported or possible ALS
b. age 20-75 years;
c. disease duration <=24 months;
d. respiratory function (FVC) = 65% of expected;
e. patients must understand and accept the protocol requirements, and must give a written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

a. previous polio infection ;
b. motor neuron diseases other than ALS (progressive bulbar palsy , progressive muscular atrophy , primary lateral sclerosis );
c. clinical involvement of other neurological systems (sensory, extrapyramidal , oculomotor, cerebellar);
d. serious clinical conditions such as cardiovascular disease, uncontrolled hypertension, renal or hepatic impairment , dysthyroidism , Respiratory Distress Syndrome (ARDS) , sickle-cell anaemia;
e. subjects who have participated in any drug trial within 12 weeks prior to recruitment;
f . concomitant malignancy, present or past, with the exception of different melanoma skin cancers and carcinoma in situ of the cervix;
g . patients with severe congenital neutropaenia syndrome with abnormal cytogenetics;
h . patients with rare hereditary problems of fructose intolerance;
i . present or past malignant myeloproliferative diseases, secondary polycythemia, splenomegaly with a diameter> 14 cm, thrombophilia was found;
j . presence of percutaneous gastrostomy at the time of recruitment ;
k . presence of NIV at the time of recruitment;
l. subjects who have participated in any drug trial within 12 weeks prior to recruitment;
n . drug addiction , alcoholism, or psychiatric disorders;
o . women who are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified