Transplantation of Autologous Peripheral Blood Mononuclear Cells for Amyotrophic Lateral Sclerosis

NCT03085706 | Completed DMC

• 1 other identifier: LCKY2016-58
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety of peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• adverse events of autologous peripheral blood mononuclear cell mobilization

  To assess the safety of autologous peripheral blood mononuclear cell transplantation

  1 week after operation

Secondary Outcomes (3)

• Functional independence measurement(FIM)

  changes of preoperation and week 1, week 2, week 4, week 12 after operation

• Berg Balance Scale

  changes of preoperation and week 1, week 2, week 4, week 12 after operation

• Dysarthria Assessment Scale

  changes of preoperation and week 1, week 2, week 4, week 12 after operation

Study Arms (1)

PBMC autotransplantation

EXPERIMENTAL

Fourteen amyotrophic lateral sclerosis (ALS) patients are received peripheral blood mononuclear cell (PBMC) autotransplantation.

Biological: PBMC autotransplantation

Interventions

PBMC autotransplantation BIOLOGICAL

Fourteen amyotrophic lateral sclerosis (ALS) patients are received peripheral blood mononuclear cell (PBMC) autotransplantation.

PBMC autotransplantation

Eligibility Criteria

• Age: 31 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all subjects had a verifiable diagnosis of ALS for 0.5 to 2 years based on a diagnosis using the Revised Criteria of the World Federation of Neurology. The grades of diagnosis were clinically definite ALS or clinically probable ALS;
• ALS was mild-to-moderate based on the ALS Functional Rating Scale-Revised. Electrophysiological features showed compound muscle action potential (CMAP) amplitude of motor nerve normal or mild declining;
• serum creatine kinase was normal or mild upper, less than 500 U/L.

You may not qualify if:

• use of any other investigational agent within 30 days before treatment;
• severe cardiac, pulmonary, hepatic or/and hematic disease;
• human immunodeficiency virus positivity or signs and symptoms consistent with human immunodeficiency virus infection;
• pregnant or nursing women;
• history of cancer with less than 5 years documentation of a disease-free state;
• history of anaphylactic reaction or hypersensitivity to granulocyte colony- stimulating factor (G-CSF);
• alcohol or drug abuse in recent 1 year;
• cannot understand or obey the rules of treatment;
• blood donor in recent 30 days.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

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

Study Officials

• Jing Liu, Ph.D.

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: 14 patients conducted at the First Affiliated Hospital of Dalian Medical University, China were eligible if they had definite or probable sporadic amyotrophic lateral sclerosis (ALS).

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

CN (1)