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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01494480
Other study ID # 20111207ALS
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received December 7, 2011
Last updated June 18, 2012
Start date March 2012
Est. completion date April 2015

Study information

Verified date June 2012
Source General Hospital of Chinese Armed Police Forces
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date April 2015
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
China Yihua An Beijing

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
within one week before,1month,6months,12months and 24months after transplantation Yes
Primary Forced vital capacity vital capacity(VC)?forced vital capacity( FVC)?forced expiratory volune(FEV1)?FEV1/FVC?maximal voluntary ventilation(MVV)?peak expiratory flow(PEF) within one week before,1month,6months,12months and 24months after transplantation Yes
Secondary 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)?a1- microglobulin?ß2- microglobulin;lymphotoxin(LCT). Tumor markers , Lymphocytes classification, cholesterol total?Triglyceride?low density lipoprotein?Glycosylated serum protein glycosylated hemoglobin?Islet function,Na+?K+ within one week before,1month,6months,12months and 24months after transplantation Yes
Secondary Urinal test proteinum?akaryocyte?a1- microglobulin?ß2- microglobulin. CSF test::IgA, IgG quantitation within one week before,1month,6months,12months and 24months after transplantation Yes
Secondary Electrophysiology examination motor evoked potential(MEP)?nerve conduction and electromyologram(EMG) within one week before,1month,6months,12months and 24months after transplantation Yes
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