Status:
UNKNOWN
Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
Lead Sponsor:
Hyun Young Kim
Conditions:
Anoxic Brain Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
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 alt...
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 fa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02210624
Start Date
March 1 2013
End Date
December 1 2018
Last Update
August 10 2017
Active Locations (1)
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1
Hanyang University Hospital
Seoul, South Korea, 133-792