The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis
This study is enrolling participants by invitation only.
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 Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 |
| Genders Eligible for Study: | Both |
| 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
No publications provided
| 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 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by General Hospital of Chinese Armed Police Forces:
|
ALS stem cell |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Motor Neuron Disease Sclerosis Central Nervous System Diseases Metabolic Diseases Nervous System Diseases |
Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies |
ClinicalTrials.gov processed this record on February 27, 2015