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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01494480
• Other study ID #: 20111207ALS
• 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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

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