Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03726814
Other study ID # EPC-BJYY-01
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date December 2018
Est. completion date December 2020

Study information

Verified date October 2018
Source Allife Medical Science and Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single centre、single arm、open-label,to investigate the safety and efficacy of EPC transplantation in the brain


Description:

The purpose of this study is to evaluate the efficacy and safety of transplantation EPCs intervent subjests with cerebral hemorrhagic stroke.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date December 2020
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Subjects = 18 and = 80 years of age

2. Subjects was confirmed cerebral hemorrhagic stroke, included at least one of risk factors(Hypertension, diabetes, coronary heart disease, high blood lipid), and Satisfied with one of the following conditions:

A. Significant stenosis (> 50%) of the intracranial and extracranial arteries or their branches due to atherosclerosis, or clinical or imaging manifestations of vascular blockage B. Head imaging (CT or MRI) : cerebral hemispheric infarct lesion diameter of > 1.5cm; Or there were more than 2 discontinuous lesions in the blood supply area of the same intracranial external artery.

C. Auxiliary examination: color ultrasonography, CTA, MRA or DSA of the blood vessels in the neck confirmed that the intracranial or extracranial stenosis was greater than or equal to 50%;

3. Serum creatinine = 1.5 mg/dl ; Serum ALT/AST)=2.5×ULN;ALB=25g/L;

4. Serum creatinine= 176.8umol/L(2.0 mg/dl);

5. Prothrombin time(PT)=15s,International standardization rates(INR)<1.7;

6. The glucose should be control between 2.8~22.2mmol/L(50~400mg/dl);

7. Adult patients were willing to use reliable contraceptives (such as condoms) and not to donate sperm throughout the study period and within three months of discharge

8. Subjects and the guardians able to undergo post-physical therapy/rehabilitation

Exclusion Criteria:

1. Non-atherogenic cerebral infarction: cardiogenic embolization, small artery occlusion type IS, other exact etiology IS, and unknown etiology IS

2. Combined with cerebral hemorrhage or previous intracranial external blood history, arteriovenous malformation and aneurysm history, or prone to hemorrhage (platelet count below 100 x 109/L)

3. The vital signs of subjects are not stable

4. Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification

5. At rest systolic pressure of 170mmHg or diastolic pressure of 105mmHg, or other indications of uncontrolled hypertension

6. Subjects have one kinds of tumors within 5 years

7. The subject was suffering from neurological or mental illness

8. Subjects had congenital or acquired immune deficiencies, active tuberculosis and other active infections (e.g., pulmonary infection, urinary tract infection, skin infection)

9. alcoholics

10. Receipt of any investigational drug or device within 3 month

11. Active hepatitis B (HBV DNA>1000copy/mL), hepatitis C or HIV infection

12. Subjects who have other conditions that were not appropriate for the group determined by the researchers.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
EPC treatment group
Brain injection EPC

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allife Medical Science and Technology Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment Emergent AE Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT03993236 - Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke Phase 4
Completed NCT04069767 - Innovative Physiotherapy in Stroke Rehabilitation N/A
Recruiting NCT06342206 - The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Enrolling by invitation NCT04956211 - Periodontal Treatment and Ischemic Stroke N/A
Active, not recruiting NCT05098236 - Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage N/A
Completed NCT03942588 - High-intensity Interval Training After Stroke N/A
Recruiting NCT04949334 - Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke N/A
Terminated NCT04095767 - Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke N/A
Not yet recruiting NCT06352086 - Understanding Visual Processing After Occipital Stroke
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Completed NCT01937182 - The Efficacy of Citalopram Treatment in Acute Stroke Phase 2
Completed NCT03649295 - Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke N/A
Recruiting NCT05303649 - Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia N/A
Completed NCT04233515 - Use of Oral Anticoagulants and Symptoms in Patients With Atrial Fibrillation in Örebro County
Completed NCT05102877 - Sensory Versus Motor Level Neuromuscular Electrical Stimulation N/A
Completed NCT04089917 - A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
Completed NCT05221112 - Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients N/A
Not yet recruiting NCT05035953 - Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke Phase 2
Completed NCT06326801 - Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients N/A