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The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
stem cell transplantation
Sponsored by
General Hospital of Chinese Armed Police Forces
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, stem cell

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnose established following the World Federation of Neurology criteria
  • More than 6 and less than 36 months of evolution of the disease
  • Medullar onset of the disease
  • More than 20 and less than 65 years old
  • Forced Vital Capacity equal or superior to 50%
  • Total time of oxygen saturation <90% inferior to 2% of the sleeping time
  • Signed informed consent

Exclusion Criteria:

  • Neurological or psychiatric concomitant disease
  • Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
  • Concomitant systemic disease
  • Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
  • Inclusion in other clinical trials
  • Unability to understand the informed consent

Sites / Locations

  • Yihua An

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell transplantation

Arm Description

After stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The patient would have to be in the bed at least 6 hours and removed the pillow.

Outcomes

Primary Outcome Measures

Nerve functional evaluation
Medical Research Council scale：To determine the strength of bilateral little finger abductor muscle and anterior tibial. To evaluate the situation of upper motor neuron impairment through the Ellis reflex scale The severity evaluation: NorrisALS score and ALS functional rating scale, ALSFRS Speed of disease progression by the following formula：Progress rate = (40-ALSFRS score) / course Questionnaires related to sleep, depression (Beck Depression Inventory) (BDI) and memory (Mini Mental State Examination)
Forced vital capacity
vital capacity(VC）、forced vital capacity( FVC）、forced expiratory volune(FEV1）、FEV1/FVC、maximal voluntary ventilation(MVV）、peak expiratory flow(PEF）

Secondary Outcome Measures

Blood test
white blood cell、neutrophilic granulocyte、leukomonocyte；glutamic pyruvic transaminase(GPT)、glutamic oxalacetic transaminase、lactate dehydrogenase(LDH)、;hydroxybutyrate dehydrogenase(HBDH)、phosphocreatine kinase(CK)；acidum uricum(UA)、creatinine(Cr)、α1- microglobulin、β2- microglobulin；lymphotoxin(LCT). Tumor markers , Lymphocytes classification, cholesterol total、Triglyceride、low density lipoprotein、Glycosylated serum protein glycosylated hemoglobin、Islet function，Na+、K+
Urinal test
proteinum、akaryocyte、α1- microglobulin、β2- microglobulin. CSF test:：IgA, IgG quantitation
Electrophysiology examination
motor evoked potential(MEP)、nerve conduction and electromyologram(EMG)

Full Information

First Posted
December 7, 2011
Last Updated
June 18, 2012
Sponsor
General Hospital of Chinese Armed Police Forces
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1. Study Identification

Unique Protocol Identification Number
NCT01494480
Brief Title
The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis
Official Title
The Clinical Study on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Chinese Armed Police Forces

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intrathecal injection of umbilical cord mesenchymal stem cells can secret trophic factors that keep the motorneurons functional. The investigators have designed a phase I/II clinical trial to check the feasibility of this approach in humans.
Detailed Description
A total of 30 diagnosed ALS patients. The patients would got these symptoms such as gait difficulty and tremor, hand incoordination or speech difficulties.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stem cell transplantation
Arm Type
Experimental
Arm Description
After stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The patient would have to be in the bed at least 6 hours and removed the pillow.
Intervention Type
Procedure
Intervention Name(s)
stem cell transplantation
Other Intervention Name(s)
the stem cell treatment of ALS
Intervention Description
after stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The patient would have to be in the bed at least 6 hours and removed the pillow.
Primary Outcome Measure Information:
Title
Nerve functional evaluation
Description
Medical Research Council scale：To determine the strength of bilateral little finger abductor muscle and anterior tibial. To evaluate the situation of upper motor neuron impairment through the Ellis reflex scale The severity evaluation: NorrisALS score and ALS functional rating scale, ALSFRS Speed of disease progression by the following formula：Progress rate = (40-ALSFRS score) / course Questionnaires related to sleep, depression (Beck Depression Inventory) (BDI) and memory (Mini Mental State Examination)
Time Frame
within one week before,1month,6months,12months and 24months after transplantation
Title
Forced vital capacity
Description
vital capacity(VC）、forced vital capacity( FVC）、forced expiratory volune(FEV1）、FEV1/FVC、maximal voluntary ventilation(MVV）、peak expiratory flow(PEF）
Time Frame
within one week before,1month,6months,12months and 24months after transplantation
Secondary Outcome Measure Information:
Title
Blood test
Description
white blood cell、neutrophilic granulocyte、leukomonocyte；glutamic pyruvic transaminase(GPT)、glutamic oxalacetic transaminase、lactate dehydrogenase(LDH)、;hydroxybutyrate dehydrogenase(HBDH)、phosphocreatine kinase(CK)；acidum uricum(UA)、creatinine(Cr)、α1- microglobulin、β2- microglobulin；lymphotoxin(LCT). Tumor markers , Lymphocytes classification, cholesterol total、Triglyceride、low density lipoprotein、Glycosylated serum protein glycosylated hemoglobin、Islet function，Na+、K+
Time Frame
within one week before,1month,6months,12months and 24months after transplantation
Title
Urinal test
Description
proteinum、akaryocyte、α1- microglobulin、β2- microglobulin. CSF test:：IgA, IgG quantitation
Time Frame
within one week before,1month,6months,12months and 24months after transplantation
Title
Electrophysiology examination
Description
motor evoked potential(MEP)、nerve conduction and electromyologram(EMG)
Time Frame
within one week before,1month,6months,12months and 24months after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnose established following the World Federation of Neurology criteria More than 6 and less than 36 months of evolution of the disease Medullar onset of the disease More than 20 and less than 65 years old Forced Vital Capacity equal or superior to 50% Total time of oxygen saturation <90% inferior to 2% of the sleeping time Signed informed consent Exclusion Criteria: Neurological or psychiatric concomitant disease Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube Concomitant systemic disease Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months Inclusion in other clinical trials Unability to understand the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YiHua An
Organizational Affiliation
Chinese People's Armed Police Force
Official's Role
Study Director
Facility Information:
Facility Name
Yihua An
City
Beijing
Country
China

12. IPD Sharing Statement

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The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis

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