NCT07208344 Intravenous Infusion of Umbilical Cord Blood as an Adjunctive Treatment for Alzheimer's Disease
| NCT ID | NCT07208344 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Alzheimer Disease (AD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-07-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07208344 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Alzheimer Disease (AD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07208344 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07208344 currently recruiting?
Yes, NCT07208344 is actively recruiting participants. Contact the research team at chengzz@USTC.edu.cn for enrollment information.
Where is the NCT07208344 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07208344 clinical trial?
NCT07208344 is sponsored by Anhui Provincial Hospital. The trial plans to enroll 30 participants.
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