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

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)

Interventions

BIOLOGICAL

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.

DRUG

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.

Sponsors & Collaborators

• Shandong Qilu Stem Cell Engineering Co., Ltd.

  collaborator UNKNOWN

• Anhui Provincial Hospital

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-31

Primary Completion

2025-12-31

Completion

2026-06-30

Countries

• China

Study Locations