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The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by General Hospital of Chinese Armed Police Forces.
Recruitment status was: Enrolling by invitation
Recruitment status was: Enrolling by invitation
Sponsor:
General Hospital of Chinese Armed Police Forces
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01494480
First received: December 7, 2011
Last updated: June 18, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Amyotrophic Lateral Sclerosis | Procedure: stem cell transplantation | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Clinical Study on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
Further study details as provided by General Hospital of Chinese Armed Police Forces:
Primary Outcome Measures:
- Nerve functional evaluation [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]
- 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 [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]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 [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]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 [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]proteinum、akaryocyte、α1- microglobulin、β2- microglobulin. CSF test:：IgA, IgG quantitation
- Electrophysiology examination [ Time Frame: within one week before,1month,6months,12months and 24months after transplantation ]motor evoked potential(MEP)、nerve conduction and electromyologram(EMG)
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: stem cell transplantation
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.
|
Procedure: stem cell transplantation
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.
Other Name: the stem cell treatment of ALS
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01494480
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494480
Locations
| China | |
| Yihua An | |
| Beijing, China | |
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
| Study Director: | YiHua An | Chinese People's Armed Police Force |
More Information
| Responsible Party: | General Hospital of Chinese Armed Police Forces |
| ClinicalTrials.gov Identifier: | NCT01494480 History of Changes |
| Other Study ID Numbers: |
20111207ALS |
| Study First Received: | December 7, 2011 |
| Last Updated: | June 18, 2012 |
Keywords provided by General Hospital of Chinese Armed Police Forces:
|
ALS stem cell |
Additional relevant MeSH terms:
|
Sclerosis Motor Neuron Disease Amyotrophic Lateral Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |
ClinicalTrials.gov processed this record on July 21, 2017