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Phase I Clinical Study of Haplo-HSCT Combined With Hypoxic 3D-Cultured Umbilical Cord MSC for the Treatment of SAA

NCT07299123 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-12

No results posted yet for this study

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

Conditions

  • Severe Aplastic Anemia (SAA)
  • Severe Aplastic Anemia, Refractory
  • Severe Aplastic Anemia

Interventions

DRUG

3D hypoxia-preconditioned UC-MSC group

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

DRUG

2D UC-MSC group

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

Sponsors & Collaborators

  • The Fourth Medical Center of Chinese PLA General Hospital

    collaborator UNKNOWN

  • Beijing 302 Hospital

    collaborator OTHER

  • The First Medical Center of Chinese PLA General Hospital

    collaborator OTHER

  • Pollon Life Co., Ltd.

    collaborator UNKNOWN

  • Yan'an University Affiliated Hospital

    collaborator OTHER

  • The University of Hong Kong-Shenzhen Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    collaborator OTHER

  • Beijing GeniusCure Biotechnology Co., Ltd.

    collaborator UNKNOWN

  • Shenzhen University General Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07299123 on ClinicalTrials.gov