Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03725865
Other study ID # iNSC-81NK-01
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date March 2019
Est. completion date March 2019

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 induction of neural stem cells transplantation in the brain


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

1. Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures.

2. Men and women 30-65 years old.

3. Women must have a negative serum pregnancy test, gestation age women practice an acceptable method of contraception.

4. At least 12 months but no more than 60 months from time of hemorrhagic stroke, with a motor neurological deficit.

5. Documented history of single hemorrhagic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI.

6. Modified Rankin Score of 2, 3 or 4.

7. FMMS score of 55 or less, two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 5 point change in the FMMS.

8. Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4 point change in the NIHSS.

9. Able and willing to undergo post-physical therapy/rehabilitation.

Exclusion Criteria:

1. Any disabling psychological or psychiatric disorders which may confound the study.

2. History of more than one hemorrhagic stroke.

3. History of another major neurological disease or injury.

4. Cerebral soften lesion size >5cm in any one measurement.

5. Myocardial infarction within the prior 3 months.

6. History of seizures or current use of antiepileptic medication.

7. History of peripheral nerve surgery, including Selective Dorsal Rhizotomy and Contralateral Seventh Cervical Nerve Transfer.

8. Receipt of any investigational drug or device within 30 days.

9. Receipt of any cell infusion other than blood transfusion.

10. Any concomitant medical disease or condition noted below:

1. Coagulopathy.

2. Active or history of malignancy.

3. Primary or secondary immune deficiency.

4. Persistent MRI artifact or unable to undergo MRI.

11. Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject.

12. Any condition that the surgeon feels may pose complications for the surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Induction of neural stem cells
Brain injection iNSC

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 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