The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT

University of Science and Technology of China (USTC)

Status and phase

Enrolling

Phase 1

Conditions

Hematopoietic Recovery

Treatments

Drug: Coenzyme I for Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06558253

coenzyme I for injection

Details and patient eligibility

About

To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.

Full description

A single-center, open-label, dose-escalation study to assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 60 years (inclusive) at screening; gender is not restricted;
Diagnosed with hematological malignancies to receive sUCBT for the first time;
No severe organ failure and no active infections
ECOG performance status of 0-2;
Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.

Exclusion criteria

Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
Pregnant patients;
Patients and/or authorised family members who refuse to receive Coenzyme I for Injection;
Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at undue risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive impairment;
Participants in other clinical studies affecting hematopoietic recovery within 3 months;
Those who are considered by the investigator to be unsuitable for enrolment (e.g., those who anticipate that the patient will not be able to adhere to the examination and treatment due to financial or other issues).