Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02492516 |
Recruitment Status :
Completed
First Posted : July 8, 2015
Last Update Posted : April 28, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Biological: mesenchymal stem cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS |
Actual Study Start Date : | September 2014 |
Actual Primary Completion Date : | March 2017 |
Actual Study Completion Date : | April 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Stem cell
The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell.
|
Biological: mesenchymal stem cells
mesenchymal stem cells injection via peripheral vein. |
- fever [ Time Frame: 72hours ]The increase of body temperature that is defined as fever, within 72 hours after injection.
- Unconsciousness [ Time Frame: 72hours ]Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
- The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) [ Time Frame: 2 months ]Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.
- FVC [ Time Frame: 2 months ]Evaluation the improvement of FVC by spirometry, 2 months after cell injection.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492516
Iran, Islamic Republic of | |
Royan Institute | |
Tehran, Iran, Islamic Republic of |
Study Chair: | Hamid Gourabi, PhD | Head of Royan Institute | |
Study Director: | Nasser Aghdami, MD,PhD | Head of department of Regenerative Medicine,Royasn Institute | |
Study Director: | Masood Nabavi, MD | Professor associated of neurology, Shahed University | |
Principal Investigator: | Leila Arab, MD | Department of Regenerative Medicine, Royan Institute |
Responsible Party: | Royan Institute |
ClinicalTrials.gov Identifier: | NCT02492516 |
Other Study ID Numbers: |
Royan-Nerve-008 |
First Posted: | July 8, 2015 Key Record Dates |
Last Update Posted: | April 28, 2017 |
Last Verified: | April 2017 |
adipose tissue mesenchymal stem cell intravenous injection ALS |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases |
Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |