NCT07299123

Brief Summary

Efficacy and Safety of Sequential Infusion of Hypoxic 3D-Cultured Umbilical Cord Mesenchymal Stem Cells in Haploidentical Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia: A Multicenter, Randomized, Phase 1 Trial

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Aug 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Aug 2023Dec 2026

Study Start

First participant enrolled

August 1, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 12, 2026

Status Verified

December 1, 2025

Enrollment Period

3.4 years

First QC Date

December 10, 2025

Last Update Submit

February 10, 2026

Conditions

Severe Aplastic Anemia, RefractorySevere Aplastic AnemiaSevere Aplastic Anemia (SAA)

Keywords

Severe Aplastic AnemiaHematopoietic Stem Cell TransplantationMesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    The incidence and severity of adverse events (AEs) within the first 150 days after haplo-HSCT

Secondary Outcomes (5)

  • acute GVHD

    100days after HSCT

  • chronic GVHD

    1 years after HSCT

  • Surivial

    1 year after HSCT

  • Rates of relapse

    UP to 2 years after HSCT

  • The implantation

    Up to 4 weeks after HSCT

Study Arms (2)

3D hypoxia-preconditioned UC-MSC group

EXPERIMENTAL
Drug: 3D hypoxia-preconditioned UC-MSC group

2D UC-MSC group

ACTIVE COMPARATOR
Drug: 2D UC-MSC group

Interventions

2D UC-MSC groupDRUG

5 × 10⁵/kg 2D UC-MSCs at 4 h before HSC infusion

2D UC-MSC group
3D hypoxia-preconditioned UC-MSC groupDRUG

5 × 10⁵/kg 3D hypoxia-preconditioned UC-MSCs at 4 h before HSC infusion

3D hypoxia-preconditioned UC-MSC group

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

28 Fuxing Road, Beijing, China.

Beijing, 100853, China

Location

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

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
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician / Associate Professor

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 23, 2025

Study Start

August 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Treatment effect

Shared Documents
STUDY PROTOCOL
Time Frame
2025/10/1-2027/1/1

Locations

CN(1)