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Stem Cell Infusion for Alzheimer's Disease

Start: August 2016
End: September 2021
Enrollment: 30

What Is This Study About?

This Phase I trial will test the safety and efficacy of an infusion of Longeveron Mesenchymal Stem Cells (LMSCs) to treat people with Alzheimer's disease. Mesenchymal stem cells have been found to counteract the neuroinflammation that contributes to the progression of Alzheimers disease.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 80 Years

Must have:

  • Weight of 45-150 kg (99-130 pounds)
  • Diagnosis of Alzheimer's disease (Mini-Mental State Examination score of 18-24; brain MRI consistent with Alzheimer's)
  • At least one adult caregiver who is fluent in the study-site language, either lives with the subject or sees the subject for at least 2 hours/day, three days/week, and agrees to accompany participant to study visits and participate in clinical assessments
  • Blood oxygen saturation of at least 93 percent, determined via pulse oximetry
  • PET scan indicating presence of beta-amyloid plaques in the cerebral cortex within 5 years of enrollment
  • Normal levels of thyroid hormone (free T4) and thyroid-stimulating hormone (TSH)
  • Normal levels of vitamin B12 and folate
  • Taking acetylcholinesterase inhibitor and/or memantine and on stable dose for at least 4 months
  • Living in the community; may include assisted living facility but not nursing facility

Must NOT have:

  • Signs of dementia other than Alzheimer's disease, such as from AIDS, Creutzfeldt-Jakob disease, Lewy body dementia
  • Any other neurodegenerative disease or serious medical condition
  • History of seizure disorder
  • Clinically important, abnormal laboratory test results beyond Alzheimer's disease
  • Any conditions that would prevent magnetic resonance imaging (e.g., presence metallic objects in the eyes, skin, or heart)
  • Any conditions that would prevent positron emission tomography (PET) scan
  • At least four cerebral microhemorrhages, a single area of superficial siderosis, or evidence of prior macrohemorrhage as assessed by MRI
  • Current use of corticosteroids or similar medication on a regular basis (exceptions include regular use of steroidal nasal sprays, topical steroids, and estrogen-replacement therapy)
  • On list to receive organ transplant or organ transplant recipient
  • Known hypersensitivity to dimethyl sulfoxide 
  • Condition expected to limit life expectancy to less than 1 year
  • Sitting or resting systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg
  • History of alcohol or drug abuse
  • History of cancer, with the exception of cured basal cell carcinoma, squamous cell carcinoma, melanoma in situ, or cervical carcinoma
  • Female who is pregnant, nursing, or of childbearing potential while not practicing effective contraception
  • Participation in any clinical trial that could influence or affect the outcome of the study
  • Hepatitis B, hepatitis C, or HIV

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 
Study Contact
Suzanne Page
Amy Drouillard

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Florida
Brain Matters Research
Delray Beach, FL 33445
University of Miami Miller School of Medicine
Miami, FL 33136
Miami Jewish Health
Miami, FL 33137

Who Sponsors This Study?

Lead: Longeveron LLC

Source: ClinicalTrials.gov ID: NCT02600130