Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
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ClinicalTrials.gov Identifier: NCT01771640 |
Recruitment Status :
Completed
First Posted : January 18, 2013
Last Update Posted : March 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Biological: intrathecal injection | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: stem cell reciepient
The patients with ALS that underwent mesenchymal stem cell transplantation
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Biological: intrathecal injection
Intrathecal injection of mesenchymal stem cells in patients with ALS |
- Fever [ Time Frame: 48hours ]Evaluation the rate of fever during 48hour after transplantation
- Unconscious [ Time Frame: 48hours ]Evaluation the rate of unconsciousness during 48hour after transplantation
- Vomiting [ Time Frame: 48hours ]Evaluation the nausea and vomiting 48hours after transplantation.
- ALS-FRS [ Time Frame: 6months ]Evaluation the improvement of ALS-FRS during 6months after transplantation.
- FVC [ Time Frame: 6months ]Evaluation the improvement of FVC by spirometry during 6months after transplantation

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age:18-65
- both gender
- duration of disease<2 years
- FVC>40% ALS-FRS>26
Exclusion Criteria:
- neurological and psychiatric concomitant disease
- concomitant systemic disease
- treatment with corticosteroid,Ig,immunosuppressive during 12 months.

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): NCT01771640
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 Royan department of degenerative medicine,Head of Royan celltherapy center | |
Study Director: | Seyed Masoud Nabavi, MD | Proffessor assistant of Shahed University | |
Principal Investigator: | leila Arab, MD | Department of regenerative medicine,Royan Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Royan Institute |
ClinicalTrials.gov Identifier: | NCT01771640 |
Other Study ID Numbers: |
Royan-Nerve-006 |
First Posted: | January 18, 2013 Key Record Dates |
Last Update Posted: | March 7, 2018 |
Last Verified: | May 2012 |
ALS intrathecal injection bone marrow mesenchymal stem cell |
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 |