The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.
| Registry | NCT03176498 |
|---|---|
| Status | Suspended - Others |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Sclnow Biotechnology Co., Ltd. (Industry) |
| Conditions | Cerebral Infarction |
| Interventions | Allogeneic umbilical cord mesenchymal stem cell, Aspirin Enteric-coated Tablets & Atorvastatin Calcium (Biological, drug) |
| Dates | start 2026-12-31 (estimated), primary completion 2027-06-30 (estimated), completion 2027-12-31 (estimated), first posted 2017-06-05, last updated 2026-04-23 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Cerebral Infarction All trials of Allogeneic umbilical cord mesenchymal stem cell All trials of Aspirin Enteric-coated Tablets & Atorvastatin Calcium
This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.
40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental group | Experimental | Biological: Allogeneic umbilical cord mesenchymal stem cell; Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium | Basic medication:Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells |
| Control group | Placebo comparator | Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium | Basic medication:Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Placebo:saline |
Sex: All, ages: 20 Years to 75 Years
Inclusion Criteria: * proved cerebral infarction by CT or MRI. * no cerebrovascular disease before * signed informed consent form Exclusion Criteria: * serious body and intracranial lesions (tumor, infection, etc.) * patients repeated cerebral infarction attacks * multi-foci of cerebral infarction * history of drug dependence and mental disease * disturbance of consciousness and non-compliance patients * subjects who are HIV positive * pregnant or lactation * donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive * subjects/ donor: alcoholism, drug addicts or mental disease
| Facility | City | Country | Status |
|---|---|---|---|
| Inner Mongolia International Mongolian Hospital | Hohhot, Inner Mongolia | China |