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Umbilical Cord Mesenchymal Stem Cell Therapy for Treatment of Aplastic Anemia: A Single-Arm, Single-Center, Open-Label, Phase 1/2 Clinical Study

Umbilical Cord Mesenchymal Stem Cell Therapy for Treatment of Aplastic Anemia: A Single-Arm, Single-Center, Open-Label, Phase 1/2 Clinical Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125907
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anemia

Interventions

Therapy Group:Umbilical Cord Mesenchymal Stem Cell

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Severe Aplastic Anemia (AA) patients with indications for hematopoietic stem cell transplantation but unable to undergo transplantation due to various factors, or for refractory non severe AA patients who have poor efficacy with existing standard treatment regimens (mainly immunosuppressants) and require regular hospitalization for component transfusions and other supportive treatments. 2. Complete clinical data. 3. 18 years old = 92% d. Left ventricular ejection fraction >= 50%. 5. Female subjects with fertility who have a negative pregnancy test result within 48 hours before infusion and are not breastfeeding. All subjects with reproductive potential should take adequate contraceptive measures before enrollment in the study and throughout the study period until 3 months after the last infusion. 6. The subjects are able to communicate well with the researchers, understand and comply with the requirements of this trial, and cooperate in completing the various examinations and follow-up specified in the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with incomplete clinical data. 2. There are serious underlying diseases, with heart, lung, liver, and kidney functions exceeding the group standards, or due to other physical problems, the researcher has assessed that it is not suitable to receive this experimental treatment. 3. Suffering from neurological, psychiatric or psychological disorders, unable to express wishes correctly or cooperate with researchers. 4. There are active infections or other chronic persistent infections such as HBV, HIV, active tuberculosis, etc. 5. Individuals with a history of malignant tumors within the past 5 years, or recently diagnosed with malignant tumors and highly suspected of having malignant tumors. 6. Pregnant or lactating women. 7. Due to other diseases, it is necessary to use concomitant medications or treatment methods that are contraindicated in this study protocol, such as vaccination. 8. Participants in other clinical trials. 9. Those who are found to be non compliant with the inclusion criteria during review or waiting for cell therapy.

Design outcomes

Primary

MeasureTime frame
Dose Limiting Toxicity;Incidence of Serious Adverse Events;

Secondary

MeasureTime frame
Overall Survival;Objective Effectiveness Rate (Complete Remission Rate+Partial Remission Rate);

Countries

China

Contacts

Public ContactZhai Zhimin

The Second Affiliated Hospital of Anhui Medical University

zzzm889@163.com+86 138 5514 7434

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026