Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients

NCT04093336 | Unknown Phase 1 DMC

• 1 other identifier: 2018-DFSC-002（V3）
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a placebo controlled, randomized, double blinded study including Phase 1 and Phase 2. Phase I study is a safety assessment and Phase 2 study is incline to assess effectiveness of MSCs. Potential subjects must be screened and consented before enrolled. The primary objective of this study is to determine the effects of early intravenous infusion of allogeneic human umbilical cord mesenchymal stem cells (HucMSCs or MSCs used in the following section) for patients with acute ischemic stroke. Eligible patients will receive a single dose of MSCs or placebo within 24 hours after stroke. Patients will be followed for 2 years post infusion for safety and efficacy (change in neurological symptoms and quality of life). Assessments will occur during transplantation and at 3,7, 14 days and1,3, 6, 12, 18 and 24 months after infusions of stem cells.

Conditions

Infarction, Middle Cerebral Artery; Infarction, Anterior Cerebral Artery; Cerebral Infarction; Stroke, Ischemic; Acute Stroke; Brain Infarction; Infarction, PCA; Infarction, Posterior Circulation, Brain

Keywords

Acute cerebral infarction ,Mesenchymal Stem Cells,prognosis

Outcome Measures

Primary Outcomes (1)

• adverse events

  include tumorigenesis, death, pulmonary embolism, allergy, newly cerebrovascular events and other adverse events to evaluate the safety of MSCs for acute ischemic stroke patients

  24 months post transplantation

Secondary Outcomes (2)

• the National Institutes of Health Stroke Scale (NIHSS) of 3 months

  3 months post transplantation

• the Barthel index (BI) of 3 months

  3 months post transplantation

Study Arms (2)

MSCs group

ACTIVE COMPARATOR

The people in this group will receive intravenous MSCs 2 x 10\^6/kg as a single dose and standardized treatment of acute ischemic stroke.

Biological: human umbilical cord mesenchymal stem cells; Other: standardized treatment

control group

PLACEBO COMPARATOR

The people in this group will receive placebo and standardized treatment of acute ischemic stroke.

Biological: Placebo; Other: standardized treatment

Interventions

human umbilical cord mesenchymal stem cells BIOLOGICAL

The MSCs was intravenous transplanted to acute cerebral infarction patients as a single dose.

MSCs group

Placebo BIOLOGICAL

Placebo

control group

standardized treatment OTHER

standardized treatment

MSCs group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke;
• Age 18\~80y;
• ≤NIHSS score≤18（including limb score≥2）and modified Rankin scale 0-1 before this cerebral ischemic stroke;
• patients and their families understand and will cooperate within the whole process of study, and sign informed consent;
• any of following items：①acute cerebral infarction confirmed by cerebral CT perfusion or non-contrast computed tomographic scan \< 7 days after onset or ②acute cerebral infarction confirmed by cerebral MR image \< 7 days after onset

You may not qualify if:

• accompanied by hematological disease, severe infection, liver dysfunction (ALT\>3\*ULN), kidney dysfunction (Scr \>2\*ULN), cardiac dysfunction (NYHA grade III or IV);
• Disturbance of consciousness, mental illness, cognitive impairment and other diseases that may affect informed consent and evaluation of study.
• Malignancy history or found to associate cancer after this stroke
• Pregnant or lactating women, or women have fertility requirements within 2 years;
• Accompanied by immunodeficiency diseases or autoimmune diseases;
• Life expectancy is less than 2 years;
• Participated in other clinical trial within 6 months;
• Patients received Chinese traditional medicine after onset of this stroke;
• Patients with allergic predisposition;
• Mental implantation or other reasons cannot tolerate magnetic resonance imaging;
• Cannot follow up regularly or unwilling to sign informed consent;
• Other situations not suitable for enrollment judged by the researchers;

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Gang Li

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Related Publications (11)

• Cao W, Li P. Effectiveness and Safety of Autologous Bone Marrow Stromal Cells Transplantation After Ischemic Stroke: A Meta-Analysis. Med Sci Monit. 2015 Jul 28;21:2190-5. doi: 10.12659/MSM.895081.

  PMID: 26215395 BACKGROUND

• GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.

  PMID: 25530442 RESULT

• Zhao Y, Yao Z, D'Souza W, Zhu C, Chun H, Zhuoga C, Zhang Q, Hu X, Zhou D. An epidemiological survey of stroke in Lhasa, Tibet, China. Stroke. 2010 Dec;41(12):2739-43. doi: 10.1161/STROKEAHA.110.586669. Epub 2010 Oct 21.

  PMID: 20966420 RESULT

• Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet. 2008 May 10;371(9624):1612-23. doi: 10.1016/S0140-6736(08)60694-7.

  PMID: 18468545 RESULT

• Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.

  PMID: 23370205 RESULT

• Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.

  PMID: 25671797 RESULT

• Lee RH, Pulin AA, Seo MJ, Kota DJ, Ylostalo J, Larson BL, Semprun-Prieto L, Delafontaine P, Prockop DJ. Intravenous hMSCs improve myocardial infarction in mice because cells embolized in lung are activated to secrete the anti-inflammatory protein TSG-6. Cell Stem Cell. 2009 Jul 2;5(1):54-63. doi: 10.1016/j.stem.2009.05.003.

  PMID: 19570514 RESULT

• Crigler L, Robey RC, Asawachaicharn A, Gaupp D, Phinney DG. Human mesenchymal stem cell subpopulations express a variety of neuro-regulatory molecules and promote neuronal cell survival and neuritogenesis. Exp Neurol. 2006 Mar;198(1):54-64. doi: 10.1016/j.expneurol.2005.10.029. Epub 2005 Dec 5.

  PMID: 16336965 RESULT

• Ikeda N, Nonoguchi N, Zhao MZ, Watanabe T, Kajimoto Y, Furutama D, Kimura F, Dezawa M, Coffin RS, Otsuki Y, Kuroiwa T, Miyatake S. Bone marrow stromal cells that enhanced fibroblast growth factor-2 secretion by herpes simplex virus vector improve neurological outcome after transient focal cerebral ischemia in rats. Stroke. 2005 Dec;36(12):2725-30. doi: 10.1161/01.STR.0000190006.88896.d3. Epub 2005 Nov 10.

  PMID: 16282547 RESULT

• Ren G, Chen X, Dong F, Li W, Ren X, Zhang Y, Shi Y. Concise review: mesenchymal stem cells and translational medicine: emerging issues. Stem Cells Transl Med. 2012 Jan;1(1):51-8. doi: 10.5966/sctm.2011-0019. Epub 2011 Dec 7.

  PMID: 23197640 RESULT

• Vu Q, Xie K, Eckert M, Zhao W, Cramer SC. Meta-analysis of preclinical studies of mesenchymal stromal cells for ischemic stroke. Neurology. 2014 Apr 8;82(14):1277-86. doi: 10.1212/WNL.0000000000000278. Epub 2014 Mar 7.

  PMID: 24610327 RESULT

MeSH Terms

Conditions

Infarction, Middle Cerebral Artery; Infarction, Anterior Cerebral Artery; Cerebral Infarction; Ischemic Stroke; Stroke; Brain Infarction; Infarction, Posterior Cerebral Artery

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Gang Li, Doctor

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Li, Doctor

CONTACT

0086-021-38804518-22106; ligang@tongji.edu.cn

Lian Zuo, Doctor

CONTACT

0086-021-38804518-22106; mizzmy@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: placebo controlled, randomized, double blinded

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: January 13, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)