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Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
mesenchymal stem cells
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring adipose tissue mesenchymal stem cell intravenous injection ALS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell

Arm Description

The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell.

Outcomes

Primary Outcome Measures

fever
The increase of body temperature that is defined as fever, within 72 hours after injection.
Unconsciousness
Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.

Secondary Outcome Measures

The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.
FVC
Evaluation the improvement of FVC by spirometry, 2 months after cell injection.

Full Information

First Posted
June 24, 2015
Last Updated
April 26, 2017
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02492516
Brief Title
Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
Official Title
Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.
Detailed Description
the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS> 24 and (Forced Vital Capacity) FVC>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
adipose tissue mesenchymal stem cell intravenous injection ALS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of department of Regenerative Medicine,Royasn Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Masood Nabavi, MD
Organizational Affiliation
Professor associated of neurology, Shahed University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leila Arab, MD
Organizational Affiliation
Department of Regenerative Medicine, Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://royaninstitute.com
Description
Related Info

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Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

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