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Intravenous Infusion of Umbilical Cord Blood as an Adjunctive Treatment for Alzheimer's Disease

RecruitingEARLY Phase 1Ages 50 Years - 75 YearsAllAnhui Provincial Hospital
NCT07208344 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a single-center, prospective, double-blind, randomized controlled clinical trial (RCT). Employing a parallel-group design, the trial plans to enroll 30 clinically diagnosed AD patients, who will be randomly assigned via a computerized randomization tool into three equal groups: low-dose, high-dose, and control (10 patients per group). The blinded clinical trial consists of three phases: \*\*Screening Phase\*\*: All enrolled patients must provide fully informed consent and meet inclusion criteria while avoiding exclusion criteria. Baseline assessments will be recorded, and single-cell omics samples will be collected. Patients may voluntarily opt for cerebrospinal fluid (CSF) sampling. The umbilical cord blood (UCB) used clinically is sourced from the Shandong Cord Blood Hematopoietic Stem Cell Bank. Following erythrocyte and granulocyte depletion via lymphocyte separatio

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age range: 50 - 75 years old, gender not restricted; * Patients diagnosed with Alzheimer's disease (AD) according to the AT(N) diagnostic framework (with positive amyloid protein PET test results); * MMSE score between 15 and 30 points, patients with mild to moderate Alzheimer's disease; * The patient has a fixed caregiver who is willing to accompany the patient throughout the corresponding program; * The patient has a literacy level above primary school, sufficient to complete the tests stipulated in the program; * The patient or the guardian consents to participate in this clinical trial voluntarily and signs the informed consent form. Exclusion Criteria: * Dementia caused by other diseases, such as vascular dementia, frontotemporal dementia, and Lewy body dementia, etc.; * The patient has other major systemic diseases, malignant tumors, chronic obstructive pulmonary disease or pulmonary fibrosis, etc. related to the lungs; * The patient's white blood cell and neutrophil levels are below the normal lower limit; * The patient has active infectious diseases, such as syphilis, AIDS, hepatitis B, hepatitis C; * The patient has a history of stroke, epilepsy, alcohol abuse, or abuse of psychotropic drugs; * Severe visual or hearing impairment, or those who cannot complete the relevant assessment due to other reasons; * Patients who have participated in other clinical trials within the last 2 months; * Other situations that the researchers consider not suitable for participating in clinical research.
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What it tests

  • Intravenous infusion of mononuclear cells from umbilical cord blood
  • Conventional medical treatment：donepezil, rivastigmine or galantamine
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Where

1 site
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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