The STem Cell Application Researches and Trials In NeuroloGy-2 (STARTING-2) Study

NCT ID: NCT01716481

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-12-31

Brief Summary

The objectives of this study was to test hypothesis that ischemic stroke patients having moderate to severe persistent neurologic deficit will have better outcomes with intravenous transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum that is obtained at acute phase of stroke than patients receiving standard treatment.

Detailed Description

In this study, we will use autologous 'ischemic' serum that obtained at the earliest time point as possible (immediate after randomization) for the purpose of ischemic preconditioning. We have recently conducted preclinical studies on the effects of ischemic preconditioning on the MSC functions. We have evaluated the characteristics of rat MSCs after culture with fetal bovine serum (FBS) or serum obtained from rat stroke model. Compared to FBS, the use of serum obtained from rat stroke model resulted in more rapid expansion of MSCs, which reduces cell preparation time by increase in G2/M phase, decreased cell death/senescence, increased trophic factor secretion, and increased migration capacity.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesenchymal stem cell treatment

Group Type: EXPERIMENTAL

Mesenchymal stem cell

Intervention Type: OTHER

intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum

Standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mesenchymal stem cell

intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Men or women (women must be of non-child bearing potential), age 30-75 yrs.

2. Have a stroke that is observed within 90 days of the onset of symptoms

3. Radiologically

1. Relevant lesions within the middle cerebral artery territory (MCA) as assessed using diffusion-weighted imaging (DWI).

2. The maximum diameter of the stroke region in any dimension must be ≥15 mm.

3. Not involving more than a half of the ipsilateral periventricular zone

4. Clinically (National Institutes of Health stroke scale, NIHSS)

1. Moderate-to severe persistent neurologic deficit (NIHSS of 6-21 inclusive)

2. New onset of extremity paresis on the affected side, defined as a score of 2-4 on the NIHSS Motor Arm (item 5) or Leg (item 6) question.

3. Must be alert or drowsy but easily arousable as defined by score of 0-1 on the NIHSS Level of Consciousness question (item 1).

4. "Slow recovery" defined as Change in NIHSS ≤1 point/3 days

5. Willingness

1. Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits.

2. Able to participate in the evaluation process to the point of accurate assessment.

3. Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures.

4. Evidence of a personally signed and dated informed consent document.

Exclusion Criteria

1. Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke modified Rankin score of 2 or more.

2. Have a stroke that is either

1. lacunar infarction

2. Hematologic cause of stroke

3. Recurrent or progressive stroke within 1 week at the time of screening.

3. Hematologic disorders or bone marrow suppression.

4. Have a severe medical illness

1. Severe heart failure

2. Severe febrile illness

3. Hepatic or renal dysfunction

4. Active cancer

5. Any evidence of chronic co-morbid condition or unstable acute systemic illnesses which, in the opinion of the investigator, could shorten the subject's survival or limit ability to complete the study.

5. Presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis on admission blood tests

6. Presence of depression that is active and not adequately controlled such that it interfere with major activities of daily living immediately prior to the current stroke.

7. Presence of dementia prior to the current stroke that is likely to confound clinical evaluation.

8. Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test or lactating females.

9. Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol

10. Subjects unwilling to undergo bone marrow aspiration

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Oh Young Bang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oh Young Bang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Oh Young Bang, MD

Role: CONTACT

nmboy@unitel.co.kr

82-10-3410-3599

Sang Ae Park, RN

Role: CONTACT

sa0124.park@samsung.com

82-10-3410-0934

Facility Contacts

Suk Jae Kim, MD

Role: primary

sukjae.kim@gmail.com

82-2-3410-1895

References

Bang OY, Kim EH, Cho YH, Oh MJ, Chung JW, Chang WH, Kim YH, Yang SW, Chopp M. Circulating Extracellular Vesicles in Stroke Patients Treated With Mesenchymal Stem Cells: A Biomarker Analysis of a Randomized Trial. Stroke. 2022 Jul;53(7):2276-2286. doi: 10.1161/STROKEAHA.121.036545. Epub 2022 Mar 28.

Reference Type: DERIVED

PMID: 35341320 (View on PubMed)

Lee J, Chang WH, Chung JW, Kim SJ, Kim SK, Lee JS, Sohn SI, Kim YH, Bang OY; STARTING-2 Collaborators. Efficacy of Intravenous Mesenchymal Stem Cells for Motor Recovery After Ischemic Stroke: A Neuroimaging Study. Stroke. 2022 Jan;53(1):20-28. doi: 10.1161/STROKEAHA.121.034505. Epub 2021 Sep 29.

Reference Type: DERIVED

PMID: 34583525 (View on PubMed)

Chung JW, Chang WH, Bang OY, Moon GJ, Kim SJ, Kim SK, Lee JS, Sohn SI, Kim YH; STARTING-2 Collaborators. Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke. Neurology. 2021 Feb 16;96(7):e1012-e1023. doi: 10.1212/WNL.0000000000011440. Epub 2021 Jan 20.

Reference Type: DERIVED

PMID: 33472925 (View on PubMed)

Kim SJ, Moon GJ, Chang WH, Kim YH, Bang OY; STARTING-2 (STem cell Application Researches and Trials In NeuroloGy-2) collaborators. Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial. Trials. 2013 Oct 1;14:317. doi: 10.1186/1745-6215-14-317.

Reference Type: DERIVED

PMID: 24083670 (View on PubMed)

Other Identifiers

2011-10-047

Identifier Type: -

Identifier Source: org_study_id