Human Umbilical Cord Blood Infusion in Patients with Acut... | NCT06040476

Studies
Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)

NCT06040476

Sponsor

StemCyte, Inc.

Status

Not yet recruiting

Last Update Posted

Feb 27, 2025Actual

Enrollment

39Estimated

Phase

Phase 2

Conditions

Acute Ischemic Stroke

Interventions

hUCB

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2025Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Aug 2028Estimated

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Sep 13, 2023

First Posted Date

Sep 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2025

Last Update Posted Date

Feb 27, 2025Actual

Name	Class
StemCyte Taiwan Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke

Detailed Description

This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the patients with acute ischemic stroke (AIS).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A group: hUCB treatment	Experimental	Human cord blood infusion	Biological: hUCB
B group: Placebo treatment	No Intervention	Placebo infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hUCB	Biological	hUCB	A group: hUCB treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety-TEAE	Frequency and incidence of treatment-emergent adverse events (TEAEs).	From screening to 48 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subject ≥18 and ≤80 years of age.
Subject with a confirmed diagnosis of AIS and hemiplegia

Exclusion Criteria:

Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Chieh Bobo Chen, PhD	Contact	02-26013013 Ext809		bobo.chen@stemcyte.com.tw

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided