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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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

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

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

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the criteria for this clinical trial limited to those over a certain age?

"To meet the requirements for this trial, a patient must be aged between 45 and 80. There are 13 studies targeting patients younger than 18 years old while 529 trials are available to those over 65."

Answered by AI

How many individuals are being enrolled to participate in this research?

"Yes, the latest information from clinicaltrials.gov shows that this study is actively seeking participants. It was initially posted on August 14th 2023 and most recently updated on August 17th 2023. 18 patients are being recruited at 1 site in total."

Answered by AI

Does this study still have openings for willing participants?

"Confirmed. Data hosted on clinicaltrials.gov declares that, since the trial's initial posting of August 14th 2023, it has been actively recruiting for 18 patients at 1 site. The information was most recently updated 7 days ago on 8/17/2023."

Answered by AI

To what extent is RB-ADSC low dose considered a safe treatment for individuals?

"There is only a small amount of evidence concerning the safety and efficacy of RB-ADSC low dose, so it received a score of 1."

Answered by AI

Is eligibility for this clinical trial currently open to new applicants?

"This medical intervention requires 18 individuals between 45 and 80 years of age who are currently diagnosed with Alzheimer's disease. Moreover, these participants must possess adequate cognitive functioning, have no tumors or other diseases that could lead to dementia, display well-controlled comorbidities whilst being on stable medications for 3 months; be in good health overall; have a relative/caregiver present during the trial; and donate an ample amount of lipoaspirate to finish off the study."

Answered by AI

Who else is applying?

What site did they apply to?

Hoag Memorial Hospital Presbyterian

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

It came up on Facebook. I have memory problems and also confusion from time to time. I was diagnosed with MS when I was in my late 20s. No exacerbations since my 30s. I have some residual symptoms, but nothing more. I am 77 years old and now I can sense some residual symptoms. That’s it! I may not be fit for this trial, but I thought I would try anyway. I might be of some interest to you for research.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

RB-ADSC for Treatment of Mild to Moderate Alzheimer's Disease

2023. "RB-ADSC for Treatment of Mild to Moderate Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05667649.

All > Alzheimers Disease Anaheim