Hypoxic Ischemic EncephalopathyPhase 1NCT01962233
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy
A Phase 1 study testing mesenchymal stem cells in people with Hypoxic Ischemic Encephalopathy, run by Hebei Medical University at 1 site in China.
Trial summary
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy
- What is being tested?
- mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients are screened foe enrollment in the study if both clinal signs and laboratory tests meet the diagnosis standards recommended by International Classification of Diseases-10 about hypoxic ischemic encephalopathy.
Who cannot join
- Exclusion Criteria are any clinically significant diseases in liver,kidney,and heart. additional exclusion criteria are no pregnancy,no immunosuppressive medication, no tumor, no viral diseases or diseases associated with immunodeficiency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
Ping Gu, Doctor, 86-311-85917297, gpwh2000@126.com
About this study
Official title: Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.
Read the detailed description
To date,hypoxic ischemic encephalopathy is refractory, including after carbon monoxide poisoning, cardiopulmonary resuscitation,hemorrhagic shock and cerebral infarction etc. We used Mesenchymal Stem Cells via portal vein infusion method to treat hypoxic ischemic encephalopathy. With different durations of follow-up, we cleared therapeutic effect, the quality of life and prognostic implications of the cord blood stem cell infusion on hypoxic ischemic encephalopathy, and evaluated the adverse reactions, through the neurological function score (NIHSS，Barthel Index), cognitive score (MoCA, MMSE),and the international uniform Parkinson Rating Scale score (UPDRS). Here, we seek new means for the treatment of hypoxic ischemic encephalopathy, and provide the basis for clinical for further application of umbilical cord blood derived Mesenchymal stem cells.
On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect. The neurological function score (NIHSS score, Barthel Index) was observed in patients with the ability to live independently and prognosis; MoCA, MMSE were used in the evaluation of cognitive function ；UPDRS was used in the evaluation of extrapyramidal tract function.
- Conditions
- Hypoxic Ischemic Encephalopathy
- Being tested
- mesenchymal stem cells
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsBiological
Procedure: On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect.
Intravenous infusion of umbilical cord derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Umbilical Cord Derived Mesenchymal Stem Cells at a dose of 100-800 million by intravenous infusion Receives: Biological: mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale (NIHSS) scores.
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).
Measured: 180 days
Secondary outcomes (5)
The Barthel Index
The Barthel Index measures 10 activities of daily living and mobility. A score of 100 is best (able to live at home with a degree of independence), 0 is worst.
Measured: before treatment and post cell transplantation:15,90,180 days
The Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function.
Measured: before treatment and post cell transplantation:15,90,180 days
The Montreal Cognitive Assessment(MoCA)
The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment.
Measured: before treatment and post cell transplantation:15,90,180 days
Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.
Measured: before treatment and post cell transplantation:15,90,180 days.
adverse reaction
adverse reaction include temperature changes,the change of blood pressure,anaphylaxis,seizure,renal dysfunction,or hepatic injury by monitoring blood routine, urinalysis, ALT,AST,Urea,Crea and electrocardiogram etc.
Measured: post cell transplantation:15,90,180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quanhai Li, Hebei Medical University
- Investigators
- Baoyong Yan, Doctor, Study chair, The First Hospital of Hebei Medical UniversityPing Gu, Doctor, Study director, The First Hospital of Hebei Medical UniversityYanyong Wang, Doctor, Principal investigator, The First Hospital of Hebei Medical UniversityLina Zhang, Master, Principal investigator, The First Hospital of Hebei Medical UniversityJun Zhang, Master, Principal investigator, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962233
- Sponsor's protocol ID
- 12276102D-Neurologic Disorder
- Status last verified
- Sep 2013
- First submitted
- 11 Sep 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT01962233
- Acronym / sponsor ID
- 12276102D-Neurologic Disorder
- Conditions
- Hypoxic Ischemic Encephalopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.
Detailed description
To date,hypoxic ischemic encephalopathy is refractory, including after carbon monoxide poisoning, cardiopulmonary resuscitation,hemorrhagic shock and cerebral infarction etc. We used Mesenchymal Stem Cells via portal vein infusion method to treat hypoxic ischemic encephalopathy. With different durations of follow-up, we cleared therapeutic effect, the quality of life and prognostic implications of the cord blood stem cell infusion on hypoxic ischemic encephalopathy, and evaluated the adverse reactions, through the neurological function score (NIHSS，Barthel Index), cognitive score (MoCA, MMSE),and the international uniform Parkinson Rating Scale score (UPDRS). Here, we seek new means for the treatment of hypoxic ischemic encephalopathy, and provide the basis for clinical for further application of umbilical cord blood derived Mesenchymal stem cells.
On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect. The neurological function score (NIHSS score, Barthel Index) was observed in patients with the ability to live independently and prognosis; MoCA, MMSE were used in the evaluation of cognitive function ；UPDRS was used in the evaluation of extrapyramidal tract function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: mesenchymal stem cellsUmbilical Cord Derived Mesenchymal Stem Cells at a dose of 100-800 million by intravenous infusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are screened foe enrollment in the study if both clinal signs and laboratory tests meet the diagnosis standards recommended by International Classification of Diseases-10 about hypoxic ischemic encephalopathy.
Key exclusion criteria (1 listed)
- Exclusion Criteria are any clinically significant diseases in liver,kidney,and heart. additional exclusion criteria are no pregnancy,no immunosuppressive medication, no tumor, no viral diseases or diseases associated with immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stem cellsProcedure: On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect. Intravenous infusion of umbilical cord derived mesenchymal stem cells | Biological | mesenchymal stem cells |
Primary outcome
National Institutes of Health Stroke Scale (NIHSS) scores.
Time frame: 180 days
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).
5 secondary outcomes
The Barthel Index
Time frame: before treatment and post cell transplantation:15,90,180 days
The Mini-Mental State Examination (MMSE)
Time frame: before treatment and post cell transplantation:15,90,180 days
The Montreal Cognitive Assessment(MoCA)
Time frame: before treatment and post cell transplantation:15,90,180 days
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: before treatment and post cell transplantation:15,90,180 days.
adverse reaction
Time frame: post cell transplantation:15,90,180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baoyong Yan, Doctor study chair
The First Hospital of Hebei Medical University
Ping Gu, Doctor study director
The First Hospital of Hebei Medical University
Yanyong Wang, Doctor principal investigator
The First Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mesenchymal stem cells in people with Hypoxic Ischemic Encephalopathy, run by Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Gu, Doctor (86-311-85917297, gpwh2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale (NIHSS) scores. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.