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

NCT01494480 | Unknown Phase 2 DMC

• 1 other identifier: 20111207ALS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; stem cell

Outcome Measures

Primary Outcomes (2)

• Nerve functional evaluation

  1. Medical Research Council scale：To determine the strength of bilateral little finger abductor muscle and anterior tibial. 2. To evaluate the situation of upper motor neuron impairment through the Ellis reflex scale 3. The severity evaluation: NorrisALS score and ALS functional rating scale, ALSFRS 4. Speed of disease progression by the following formula：Progress rate = (40-ALSFRS score) / course 5. 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

• 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

Secondary Outcomes (3)

• Blood test

  within one week before,1month,6months,12months and 24months after transplantation

• Urinal test

  within one week before,1month,6months,12months and 24months after transplantation

• Electrophysiology examination

  within one week before,1month,6months,12months and 24months after transplantation

Study Arms (1)

stem cell transplantation

EXPERIMENTAL

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

Interventions

stem cell transplantation PROCEDURE

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.

Also known as: the stem cell treatment of ALS

stem cell transplantation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unability to understand the informed consent

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead

Study Sites (1)

Yihua An

Beijing, China

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• YiHua An

  Chinese People's Armed Police Force

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 19, 2011
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2015
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

CN (1)