Intravenous umbilical cord blood cell infusion alongside standard Alzheimer's medication
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
This trial will try giving an IV infusion of umbilical cord blood mononuclear cells to people aged 50–75 with mild to moderate Alzheimer's alongside their usual medications to see if it helps symptoms or biological disease markers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07208344 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, double-blind early phase 1 trial will enroll 30 AT(N)-confirmed Alzheimer's patients and randomize them equally to low-dose, high-dose, or control groups. All participants continue conventional cholinesterase therapies while receiving one of the blinded interventions: processed umbilical cord blood mononuclear cell infusions or control. The cord blood product is obtained from a certified bank and processed to deplete erythrocytes and granulocytes to reduce immunogenicity; baseline clinical assessments, single-cell omics sampling, and optional CSF collection are planned. The study focuses on safety and preliminary signals of biological or clinical effect from the cell infusions.
Who should consider this trial
Good fit: Ideal candidates are 50–75 years old with mild to moderate Alzheimer's confirmed by a positive amyloid PET, an MMSE of 15–30, a reliable caregiver, and the ability to complete study visits and tests.
Not a fit: Patients with dementias due to other causes, major systemic illnesses, or other exclusion criteria are unlikely to benefit and are not eligible for the intervention.
Why it matters
Potential benefit: If successful, the infusions could slow cognitive decline or improve clinical and biological measures beyond standard medications.
How similar studies have performed: Preclinical work and a few small early-phase human studies of cord blood or related cell therapies have shown safety and suggestive biological signals, but clear clinical benefit in Alzheimer's has not been established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of the University of Science and Technology of China — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Zhaozhao Cheng
- Email: chengzz@USTC.edu.cn
- Phone: +8613965140655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.