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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
Must not have
Neurological disorders except AD
Participants with a history of cancer in the past 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am between 45 and 80 years old.
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I do not have dementia caused by tumors or disease.
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I can provide enough fat tissue for the treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neurological condition, but it's not Alzheimer's disease.
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I have had cancer within the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The safety of RB-ADSC treatment in study participants with AD
Secondary study objectives
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)
Change from Baseline in Mini Mental State Examination (MMSE)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Regeneration Biomedical, Inc.Lead Sponsor

Media Library

RB-ADSC (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05667649 — Phase 1
Alzheimer's Disease Research Study Groups: RB-ADSC medium dose, RB-ADSC low dose, RB-ADSC high dose
Alzheimer's Disease Clinical Trial 2023: RB-ADSC Highlights & Side Effects. Trial Name: NCT05667649 — Phase 1
RB-ADSC (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05667649 — Phase 1
~1 spots leftby Feb 2025
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