Clinical trial NCT02210624: Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
Official title: An Open-label, Safety and Efficacy Assessment of Autologous Bone-marrow Derived Mesenchymal Stem Cell Therapy in Anoxic (or Hypoxic) Brain Injury.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anoxic Brain Injury
Keywords: Anoxic Brain Injury
Autologous bone marrow derived stem cell
stoke
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an emerging alternative treatment modality in incurable and intractable neurological disorders. This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain injury.

Detailed description: Various treatment modalities to minimize the neurological deficits of anoxic brain injury, including lower consciousness, abnormal movement disorders, and abnormal behavior, have been tried, but so far there have been no effective proven method for chronic patients.

This study is the investigator initiated trial to verify the safety and feasibility of stem cells therapy in patients with anoxic brain injury.

Eligibility criteria: Inclusion Criteria:

* Patients older than 14 days after the index event occurs in an oxygen-free brain injury patients
* Severe disability or moderate due to anoxic brain injury
* 18 years to 75 years
* Patients was 7 points less than Glasgow coma scale (GCS) After the resumption of blood flow circulation.
* anaerobic unexpected (hypoxic) cerebral ischemia Encephalopathy (It should not be a hypoxic brain ischemia was induced due to heart surgery, which is scheduled)
* Subjects agreed in writing that it will be participating in clinical research, as viewed from the legal representative (patient)

Exclusion Criteria:

* Patients who require ventilator continued
* Patients who had extracorporeal membrane oxygenation(ECMO) index event occurs at the time
* Patients who had a history of cardiac arrest prior to the occurrence of Index event
* End-stage people of less than 12 months is expected (incurable) disease patients
* Patients with cardiac arrest occurred due to brain trauma severe
* Patients with damage to other organs of severe
* Patients with bleeding or malignant current
* Pregnant patient
* Patients with central nervous system tumors undergoing radiation therapy or chemotherapy
* If the patient or are participating in other clinical trials, you are planning to participate, or patients three months after the end is not passed to participate in other clinical trials

Primary outcomes:
measure: safety assessment
timeFrame: week 1, 3, 4, 5, 7
Secondary outcomes:
measure: Glasgow Coma Scale(GCS)
timeFrame: Week 1, 4, 5, 6, 7
measure: FOUR score
timeFrame: Week 1, 4, 5, 6, 7
measure: Functional Independence Measure(FIM)
timeFrame: Week 1, 4, 5, 6, 7
measure: Disability Rating Scale(DRS)
timeFrame: Week 1, 4, 5, 6, 7
measure: Cerebral Performance Category(CPC)scale
timeFrame: Week 1, 4, 5, 6, 7
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
affiliation: Hanyang University
name: Hyun Young Kim, MD.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: