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Stem Cell Therapy
Stem Cell Therapy for Alzheimer's Disease
Phase 1
Recruiting
Research Sponsored by Regeneration Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥45 and ≤80 years of age
No tumors or other disease responsible for dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
Study Summary
This trial seeks to test whether using cells from one's own fat can help treat Alzheimer's.
Who is the study for?
This trial is for individuals aged 45-80 with mild to moderate Alzheimer's Disease, who can donate their own fat tissue for treatment and have a caregiver. Participants should be in good health, with stable medications for other conditions, and no recent cancer or stem cell treatments.Check my eligibility
What is being tested?
The study tests the safety of RB-ADSC, a new therapy using participants' own fat-derived cells to treat Alzheimer's. It aims to see if this approach is safe and how it affects the disease symptoms.See study design
What are the potential side effects?
Since RB-ADSC uses the participant's own cells, side effects may be limited but could include reactions at the donation or injection site, potential immune responses, or unforeseen impacts on cognitive functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 80 years old.
Select...
I do not have dementia caused by tumors or disease.
Select...
I can provide enough fat tissue for the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The safety of RB-ADSC treatment in study participants with AD
Secondary outcome measures
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)
Change from Baseline in Mini Mental State Examination (MMSE)
Trial Design
3Treatment groups
Experimental Treatment
Group I: RB-ADSC medium doseExperimental Treatment1 Intervention
Participants will receive one dose of 5x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir
Group II: RB-ADSC low doseExperimental Treatment1 Intervention
Participants will receive one dose of 2x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir
Group III: RB-ADSC high doseExperimental Treatment1 Intervention
Participants will receive one dose of 10x10^6 RB-ADSC infused in the previously implanted Ommaya reservoir
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Who is running the clinical trial?
Regeneration Biomedical, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thinking and memory skills are good.My other health conditions are stable and I've been on the same medication for 3 months.I have a neurological condition, but it's not Alzheimer's disease.I have not had any stem cell implantation in the last 3 months.I have had cancer within the last 5 years.I have been diagnosed with mild to moderate Alzheimer's disease.I do not have dementia caused by tumors or disease.You are generally healthy with no major health problems.I can provide enough fat tissue for the treatment.I am between 45 and 80 years old.I can sign the consent form on my own.You have certain mental health conditions like schizophrenia, bipolar disorder, and severe depression.You have struggled with drug or alcohol addiction in the past 5 years.I am on stable doses of certain Alzheimer's medications for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: RB-ADSC low dose
- Group 2: RB-ADSC medium dose
- Group 3: RB-ADSC high dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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