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Stem Cell Therapy

Stem Cell Therapy for Glioblastoma

Phase 1

Recruiting

Led By Alfredo Quinones-Hinojosa, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients have undergone previous standard of care as outlined by Stupp et al. (2004) which include maximal safe resection followed by concomitant radiation therapy and chemotherapy with oral temozolomide

Participants aged between 18 and 65 years

Must not have

Tumors located in the brain stem, midbrain, or thalamus

Previous treatment with bevacizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy to improve outcomes in patients with glioblastoma, the most aggressive form of brain tumor. It uses cells from body fat to reduce tumor growth & spread and increase chemo resistance.

Who is the study for?

This trial is for adults aged 18-65 with recurrent glioblastoma who've had standard treatment and are now undergoing brain surgery. They must have certain normal blood, liver, and kidney functions, understand the study, consent to provide samples for research, not be pregnant or breastfeeding if applicable, and agree to follow-up visits.

What is being tested?

The trial tests allogenic adipose-derived mesenchymal stem cells (AMSCs) delivered into the surgical cavity during craniotomy in patients with recurrent glioblastoma. It aims to find a safe dose that might slow tumor growth and improve survival by affecting residual tumor cells after surgery.

What are the potential side effects?

Potential side effects may include reactions at the injection site within the brain cavity where AMSCs are administered. Since this is an early-phase trial assessing safety, detailed side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had surgery, radiation, and chemotherapy with temozolomide for my condition.

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I am between 18 and 65 years old.

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I can care for myself but may need occasional help.

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I have a GBM diagnosis with a recurring tumor at the same spot and am set for another surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor is in the brain stem, midbrain, or thalamus.

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I have been treated with bevacizumab before.

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I am only having a biopsy or cannot have surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Best response

Incidence of adverse events (AEs)

Overall survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (AMSCs)Experimental Treatment5 Interventions

Patients receive AMSCs IT and undergo Ommaya reservoir placement during a craniotomy on study. Patients also undergo MRI on study and during follow-up, as well as blood sample, tissue sample, and CSF sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Craniotomy

2016

N/A

~740