|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02492516 |
|
Date of registration:
|
24/06/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
|
|
Scientific title:
|
Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS |
|
Date of first enrolment:
|
September 2014 |
|
Target sample size:
|
19 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02492516 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Iran, Islamic Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Masood Nabavi, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Professor associated of neurology, Shahed University |
|
|
Name:
|
Leila Arab, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Regenerative Medicine, Royan Institute |
|
|
Name:
|
Hamid Gourabi, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Head of Royan Institute |
|
|
Name:
|
Nasser Aghdami, MD,PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Head of department of Regenerative Medicine,Royasn Institute |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Both gender
- Age: 18-55
- Sporadic form of disease
- ALS-FRS> = 24
- FVC >= 40%
Exclusion Criteria:
- Familial form of ALS
- Malignancy
- Autoimmune disease
- Diagnosis of other motor neuron diseases
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Amyotrophic Lateral Sclerosis
|
|
Intervention(s)
|
|
Biological: mesenchymal stem cells
|
|
Primary Outcome(s)
|
|
Unconsciousness
[Time Frame: 72hours]
|
|
fever
[Time Frame: 72hours]
|
|
Secondary Outcome(s)
|
|
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
[Time Frame: 2 months]
|
|
FVC
[Time Frame: 2 months]
|
|
Secondary ID(s)
|
|
Royan-Nerve-008
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|