## Protocol Section
### Identification Module
**NCT ID:** NCT02283879

**Brief Title:** Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

**Official Title:** Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage

#### Organization Study ID Info
**ID:** HYK-Cerebral hemorrhage
#### Organization
**Class:** INDUSTRY
**Full Name:** Shenzhen Hornetcorn Bio-technology Company, LTD
### Status Module
#### Completion Date
**Date:** 2017-04

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2016-05-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-23

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-03

**Status Verified Date:** 2015-07

#### Study First Post Date
**Date:** 2014-11-05
**Type:** ESTIMATED
**Study First Submit Date:** 2014-11-03
**Study First Submit QC Date:** 2014-11-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Fifth Affiliated Hospital of Guangzhou Medical University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shenzhen Hornetcorn Bio-technology Company, LTD

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.

**Detailed Description:** Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.

To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.

### Conditions Module

**Conditions:**

- Cerebral Hemorrhage

**Keywords:**

- Human Umbilical Cord Mesenchymal Stem Cell

- Mesenchymal Stem Cell

- Cerebral hemorrhage

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

**Intervention Names:**

- Biological: Human umbilical cord mesenchymal stem cells

**Label:** hUC-MSC treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- hUC-MSC treatment

**Description:** A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.

**Name:** Human umbilical cord mesenchymal stem cells

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)

**Time Frame:** 12 months

#### Secondary Outcomes

**Measure:** Improvement of infarct size measured by brain MRI

**Time Frame:** before the transplant and 1, 6, 12 months after transplantation

**Measure:** Modified Barthel index

**Time Frame:** before and 1, 3, 6 and 12 months after transplantation

**Measure:** National Institutes of Health stroke scale(NIHSS) score

**Time Frame:** before the transplant and after the transplant 1, 2 and 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 40-70 intracerebral hemorrhage patient
* With stroke history of more than 3 months, less than 60 months
* National Institutes of Health stroke scale(NIHSS) score of 7 or more points
* Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \<7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria:

* History of neurological disease, head injury or psychiatric disorder;
* Pregnant women;
* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
* Progressive apoplexy;
* With malignant tumors.

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** The Fifth Affiliated Hospital Immunotherapy center

**State:** Guangdong

**Zip:** 510000

#### Overall Officials

**Official 1:**

**Affiliation:** Fifth Affiliated Hospital of Guangzhou Medical University

**Name:** Ping J Chen, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020300

- Term: Intracranial Hemorrhages

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5792

- Name: Cerebral Hemorrhage

- Relevance: HIGH

- As Found: Cerebral Hemorrhage

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002543

- Term: Cerebral Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Misc Info Module

- Version Holder: 2024-05-24
