Lomecel-B Effects on Alzheimer's Disease

Inclusion Criteria:

• Provide written informed consent.
• Be 60 - 85 years of age at signing of the Informed Consent Form.
• Clinical diagnosis of mild Alzheimer's disease in accordance with the NIA-AA criteriaat the time of enrollment.
• MMSE score of 19 - 23.
• Body weight of 40 - 150 kg.
• Has an adult caregiver who meets all of the following criteria.

1. Provides written informed consent to participate on the trial (reporting onpatient observations).
2. Either lives with the patient, or sees the patient for at least 2 hours/day forat least 3 days/week.
3. Is willing and able to participate in the study, and agrees to accompany thepatient to each study visit.
4. Is able to read, understand, and speak the designated language at the study site.

• Brain MRI consistent with AD.
• A PET scan using an FDA-approved tracer (e.g., AMYViD, Vizamyl, or Neuraceq)consistent with the diagnosis of AD. A prior positive PET scan will be allowed withSponsor approval.
• Living in the community, includes assisted living facilities (but excluding long-termcare nursing facilities).

Exclusion Criteria:

• Diagnosed with frontotemporal dementia (FTD), dementia due to AcquiredImmunodeficiency Syndrome (AIDS), Creutzfeldt-Jakob disease (CJD), Lewy Bodiesdementia (LBD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions,or normal pressure hydrocephalus.
• Any other neurodegenerative disease.
• History of a seizure disorder.
• Evidence of: a prior macrohemorrhage; at least 4 cerebral microhemorrhages (regardlessof anatomical location or diagnostic characterization as "possible" or "definite"); orat least 1 area of superficial siderosis.
• Unwillingness or inability to have MRIs scans (no contrasting agent will be used), orcondition that contraindicates MRI, such as the presence metallic objects in the eyes,skin, or heart.
• Any conditions that contraindicates PET with a beta-amyloid tracer.
• Significant intestinal malabsorption surgery, e.g., gastric bypass.
• Serum B12 and/or folate levels below normal range.
• Clinically abnormal free T4 or thyroid-stimulating hormone (TSH).
• Resting blood oxygen saturation <93%.
• Resting systolic blood pressure >180 mm Hg, or diastolic blood pressure >110 mm Hg.
• Regularly (> 4 weeks) using high-doses of corticosteroids or other steroidalanti-inflammatory medication (e.g., Prednisone) on a regular basis, with the exceptionof steroidal nasal sprays, asthma inhalers, topical steroids, and hormonal-replacementtherapy.
• Regularly (> 4 weeks) using anti-cytokine antibody or targeting therapy, e.g.,anti-TNF-α.
• Be an organ transplant recipient, or have active or expected future listing for anyorgan/tissue transplant while scheduled to be on trial, except for corneal, bone,skin, ligament, or tendon.
• Diagnosed with malignancy within the past 2 years, with the exception of curativelytreated basal cell carcinoma, squamous cell carcinoma, melanoma in situ, or cervicalcarcinoma.
• Known hypersensitivity to dimethyl sulfoxide (DMSO).
• Test positive for hepatitis B virus surface antigen, viremic hepatitis C virus, HIV,or syphilis.
• Any condition that is projected to limited life expectancy to < 12 months.
• Be pregnant, nursing, or of childbearing potential while not practicing effectivecontraception.
• Be currently participating in any other investigational therapeutic or device trial,or have participated within one within the previous 30 days to screening, or in theopinion of the investigator, the patient should be excluded for such participationwithin the past 5 years.
• In the opinion of the investigator, the patient has any other illness or conditionthat: may compromise the participant's safety, compliance, or ability to successfullycomplete the study; may compromise the validity of the study; or otherwise shouldexclude the participant from enrollment.