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

NCT ID: NCT07208344

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-06-30

Brief Summary

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 separation and density gradient centrifugation, the UCB is purified to reduce immunogenicity and undergoes genetic screening to exclude the APOE4 risk allele.

**Treatment Phase**: In addition to standard care, patients will receive intravenous infusions at weekly intervals for four sessions. A fifth infusion will be administered one month after the fourth. The low-dose group receives 1×10⁸ UCB-derived mononuclear cells (UCB-MNCs) per infusion, the high-dose group receives 3×10⁸ UCB-MNCs, and the control group receives an equivalent volume of saline placebo.

All clinically administered UCB-MNCs undergo genetic screening to exclude the APOE4 risk allele.

**Follow-up Phase**:

Assessments will be conducted at 30 days (1 month), 60 days (2 months), 90 days (3 months), and 180 days (6 months) post-initial infusion, including:

1. CDR-SB scale scoring;

2. Total and subdomain scores of the Activities of Daily Living (ADL) scale;

3. Serum inflammatory cytokines (IL-1, IL-2, IL-6, IL-8, IL-10, TNF-α), AD biomarkers (P-tau181, P-tau217), and other relevant markers;

4. Single-cell omics sample collection;

5. Optional CSF sampling per patient preference.

After database lock, unblinding will occur for subsequent analysis.

Conditions

Alzheimer Disease (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

The conventional treatment plan was supplemented with intravenous injection of normal saline (in a blinded manner)

Group Type: PLACEBO_COMPARATOR

Conventional medical treatment：donepezil, rivastigmine or galantamine

Intervention Type: DRUG

The treatment is carried out using drugs such as cholinesterase inhibitors (ChEI) which are suitable for mild to moderate Alzheimer's disease. For example, donepezil, rivastigmine, galantamine, etc. The frequency and dosage of drug administration should be in accordance with the instructions provided by the drug manufacturer.The patient should maintain the stability of the medication regimen throughout the entire study period.

Low-dose group

In addition to the conventional treatment regimen, intravenous infusion of umbilical cord blood mononuclear cells (1×10\^8 cells per infusion) will be administered. The infusions will be carried out via the intravenous route at one - week intervals for a total of four consecutive times. One month after the completion of the fourth infusion, the fifth infusion will be performed.

Group Type: EXPERIMENTAL

Intravenous infusion of mononuclear cells from umbilical cord blood

Intervention Type: BIOLOGICAL

When performing cell infusion, it is essential to use an infusion set and follow the standard blood transfusion procedures. Before, during, and after the infusion, monitor the patient's body temperature, pulse, breathing, and blood pressure. When infusing cells, first flush the tube with 20-30 ml of 0.9% sodium chloride, and start the infusion at a rate of 20-30 drops per minute. After half an hour, if there are no adverse reactions, increase the rate to 30-50 drops per minute. During the cell infusion process, gently shake the cell bag once every 15 minutes. After the infusion is completed, flush the cell preservation bag with 20 ml of 0.9% sodium chloride and gently shake it. After that, use 0.9% sodium chloride to rinse the infusion set to remove the cells completely, to ensure the quantity of cell infusion.

Conventional medical treatment：donepezil, rivastigmine or galantamine

Intervention Type: DRUG

The treatment is carried out using drugs such as cholinesterase inhibitors (ChEI) which are suitable for mild to moderate Alzheimer's disease. For example, donepezil, rivastigmine, galantamine, etc. The frequency and dosage of drug administration should be in accordance with the instructions provided by the drug manufacturer.The patient should maintain the stability of the medication regimen throughout the entire study period.

High-dose group

In addition to the conventional treatment regimen, intravenous infusion of umbilical cord blood mononuclear cells (3×10\^8 cells per infusion) will be administered. The infusions will be carried out via the intravenous route at one - week intervals for a total of four consecutive times. One month after the completion of the fourth infusion, the fifth infusion will be performed.

Group Type: EXPERIMENTAL

Intravenous infusion of mononuclear cells from umbilical cord blood

Intervention Type: BIOLOGICAL

When performing cell infusion, it is essential to use an infusion set and follow the standard blood transfusion procedures. Before, during, and after the infusion, monitor the patient's body temperature, pulse, breathing, and blood pressure. When infusing cells, first flush the tube with 20-30 ml of 0.9% sodium chloride, and start the infusion at a rate of 20-30 drops per minute. After half an hour, if there are no adverse reactions, increase the rate to 30-50 drops per minute. During the cell infusion process, gently shake the cell bag once every 15 minutes. After the infusion is completed, flush the cell preservation bag with 20 ml of 0.9% sodium chloride and gently shake it. After that, use 0.9% sodium chloride to rinse the infusion set to remove the cells completely, to ensure the quantity of cell infusion.

Conventional medical treatment：donepezil, rivastigmine or galantamine

Intervention Type: DRUG

The treatment is carried out using drugs such as cholinesterase inhibitors (ChEI) which are suitable for mild to moderate Alzheimer's disease. For example, donepezil, rivastigmine, galantamine, etc. The frequency and dosage of drug administration should be in accordance with the instructions provided by the drug manufacturer.The patient should maintain the stability of the medication regimen throughout the entire study period.

Interventions

Intravenous infusion of mononuclear cells from umbilical cord blood

When performing cell infusion, it is essential to use an infusion set and follow the standard blood transfusion procedures. Before, during, and after the infusion, monitor the patient's body temperature, pulse, breathing, and blood pressure. When infusing cells, first flush the tube with 20-30 ml of 0.9% sodium chloride, and start the infusion at a rate of 20-30 drops per minute. After half an hour, if there are no adverse reactions, increase the rate to 30-50 drops per minute. During the cell infusion process, gently shake the cell bag once every 15 minutes. After the infusion is completed, flush the cell preservation bag with 20 ml of 0.9% sodium chloride and gently shake it. After that, use 0.9% sodium chloride to rinse the infusion set to remove the cells completely, to ensure the quantity of cell infusion.

Intervention Type: BIOLOGICAL

Conventional medical treatment：donepezil, rivastigmine or galantamine

The treatment is carried out using drugs such as cholinesterase inhibitors (ChEI) which are suitable for mild to moderate Alzheimer's disease. For example, donepezil, rivastigmine, galantamine, etc. The frequency and dosage of drug administration should be in accordance with the instructions provided by the drug manufacturer.The patient should maintain the stability of the medication regimen throughout the entire study period.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Qilu Stem Cell Engineering Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of the University of Science and Technology of China

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaozhao Cheng

Role: CONTACT

chengzz@USTC.edu.cn

+8613965140655

Other Identifiers

AHSL-QLGXB-MNC-AD

Identifier Type: -

Identifier Source: org_study_id