Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.

NCT03176498 — Phase 1 / Phase 2, Suspended, 40 participants, Sclnow Biotechnology Co., Ltd.

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The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.

RegistryNCT03176498
StatusSuspended - Others
PhasePhase 1 / Phase 2
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment40 (Estimated)
SponsorSclnow Biotechnology Co., Ltd. (Industry)
ConditionsCerebral Infarction
InterventionsAllogeneic umbilical cord mesenchymal stem cell, Aspirin Enteric-coated Tablets & Atorvastatin Calcium (Biological, drug)
Datesstart 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
Locations1 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

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Experimental groupExperimentalBiological: Allogeneic umbilical cord mesenchymal stem cell; Drug: Aspirin Enteric-coated Tablets & Atorvastatin CalciumBasic medication:Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells
Control groupPlacebo comparatorDrug: Aspirin Enteric-coated Tablets & Atorvastatin CalciumBasic medication:Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Placebo:saline
  • Allogeneic umbilical cord mesenchymal stem cell (Biological): Experimental group receive Allogeneic umbilical cord mesenchymal stem cell,i.v (SCLnow 19#)
  • Aspirin Enteric-coated Tablets & Atorvastatin Calcium (Drug): Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

+Outcome measures

Primary outcomes

  • Motor function analysis [6 months]: Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb >60, and total score >90 is considered good recovery.

Secondary outcomes

  • Neurological deficits analysis [6 months]: According to Chinese scale of clinical neurologic deficit to analysis, the result as follow: * Excellent: after treatment, patient with consciousness, and clinical symptoms improved; * Effective: vital signs and main symptoms in remission; * Inefficient: no obvious improvement or condition worsened.
  • Limb motor function analysis [6 months]: Using fugl-meyer assessment evaluate motor function. Mild movement disorder: 96 - 99; Moderate movement disorder: 85 - 95; Obvious movement disorder: 50 - 84; Serious movement disorder: < 50
  • Barthel Index analysis [6 months]: Obvious effective: Barthel Index score between 96 - 99, patient with self care ability. Effective:Barthel Index score between 70 - 89, patient with condition improved. Invalid: The effect do not meet above standards.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Inner Mongolia International Mongolian HospitalHohhot, Inner MongoliaChina

+Investigators

  • Wulan, Study director, Inner Mongolia International Mongolian Hospital
  • Lei Guo, Dr, Study chair, China-Japan Union Hospital, Jilin University