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

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03176498
• Other study ID #: SCLnow-IMIMH-01
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: December 31, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sclnow Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Biological:
• Allogeneic umbilical cord mesenchymal stem cell
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell,i.v (SCLnow 19#)

Drug:
• Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

Locations

Country	Name	City	State
China	Inner Mongolia International Mongolian Hospital	Hohhot	Inner Mongolia

Sponsors (1)

Lead Sponsor	Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor function analysis	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.	6 months
Secondary	Neurological deficits analysis	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.	6 months
Secondary	Limb motor function analysis	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	6 months
Secondary	Barthel Index analysis	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.	6 months