Allogeneic Mesenchymal Stem Cells for the Survivors of Ischemic Stroke Trial (ASSIST)

NCT04590118 | Unknown Phase 1

• 1 other identifier: STCMSC-CT-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of single injection of it-hMSC in patients with ischemic stroke in a multicenter, blind, randomized, placebo controlled trial

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after it-hMSC infusion.

  12 months

Secondary Outcomes (5)

• Modified Rankin Scale

  month 1, month 3, month 6, month 9, month 12

• National Institute of Health stroke scale

  month 1, month 3, month 6, month 9, month 12

• Mini-mental State Examination

  month 1, month 3, month 6, month 9, month 12

• Barthel Index

  month 1, month 3, month 6, month 9, month 12

• Geriatric Depression Scale

  month 1, month 3, month 6, month 9, month 12

Study Arms (2)

Experimental: it-hMSC

EXPERIMENTAL

Single intravenous infusion of 0.5×10\^6, 1×10\^6, 2×10\^6 it-hMSC/kg

Drug: it-hMSC

Placebo-controlled: Placebo

PLACEBO COMPARATOR

Single intravenous infusion of 1 ml/kg placebo

Drug: Placebo

Interventions

it-hMSC DRUG

Single intravenous infusion of it-hMSC for ischemic stroke patients

Experimental: it-hMSC

Placebo DRUG

Single intravenous infusion of 1 ml/kg placebo

Placebo-controlled: Placebo

Eligibility Criteria

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

You may qualify if:

• years or older.
• Clinical diagnosis of ischemic stroke for more than 6 months.
• Imaging findings suggestive of ischemic stroke with functional deficits at initial diagnosis and enrollment.
• Severe neurological impairment associated with the diagnosis of ischemic stroke that resulted in the subject needing assistance to walk or not being able to perform general daily activities independently.
• No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment.
• NIHSS score between 6-20.
• Life expectancy longer than 12 months.
• Prior to treatment, the patient received standard medical care for secondary prevention of ischemic stroke, including but not limited to appropriate blood pressure and cholesterol control measures, use of antiplatelet agents or anticoagulants (except when prohibited).
• Understand and provide signed informed consent, or have a designated legal guardian or spouse make such decision voluntarily on behalf of the subject.
• Expected that the patient will receive standard medical care for secondary prevention of ischemic stroke and participate in all planned safe follow-up visits reasonably.
• Organ function as defined by the following criteria:
• AST ≤ 2.5×ULN ALT ≤ 2.5×ULN TSB ≤1.5×ULN PT ≤1.25×ULN and PTT ≤1.25×ULN in subjects who did not receive antithrombotic therapy Serum albumin ≥ 3.0g/dL ANC ≥ 1,500/μL Platelets ≥ 150,000/μL Hemoglobin ≥ 9.0g/dL Serum creatinine ≤ 1.5×ULN Serum amylase or lipase ≤ 1.0×ULN

You may not qualify if:

• History of epilepsy.
• History of cancer.
• History of brain trauma and brain tumor.
• Positive for hepatitis B surface antigen, E antigen, E antibody, core antibody, hepatitis C, HIV or RPR.
• Myocardial infarction occurred within six months of study entry.
• Any other medical problems of clinical significance, abnormal mental or test results that the investigator or sponsor determined participating in the study pose a safety risk to the subject.
• Imaging findings suggestive of subarachnoid hemorrhage or intracerebral hemorrhage in the past 12 months.
• Participation in any study of experimental drug or device within 3 months.
• Participation in other study related to stem cell-therapy.
• History of drug or alcohol abuse within 1 year.
• Pregnant, lactating or planning to become pregnant during the trial.
• Allergic to cattle or pork products.

Sponsors & Collaborators

• Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In phase I, the masking method is open-label, whereas in phase II, the masking method is double blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: October 19, 2020
• Study Start: April 26, 2021
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)