A Randomized Double-blind Clinical Study on the Use of Umbilical Cord Blood as an Adjuvant Therapy to Improve Cognitive Function in Alzheimer's Disease and Its Mechanism of Action

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of the University of Science and Technology of China
RECRUITING
Hefei
Contact Information
Primary
Zhaozhao Cheng
chengzz@USTC.edu.cn
+8613965140655
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 30
Treatments
Placebo_comparator: Control group
The conventional treatment plan was supplemented with intravenous injection of normal saline (in a blinded manner)
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital
Collaborators: Shandong Qilu Stem Cell Engineering Co., Ltd.

This content was sourced from clinicaltrials.gov