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Stem Cell Therapy
Stem Cell Therapy for Glioblastoma
Phase 1
Recruiting
Led By Alfredo Quinones-Hinojosa
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Best response
Incidence of adverse events (AEs)
Overall survival
+2 moreTrial 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 and CSF sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Craniotomy
2016
N/A
~740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,468 Total Patients Enrolled
14 Trials studying Glioblastoma
779 Patients Enrolled for Glioblastoma
Alfredo Quinones-HinojosaPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are able to become pregnant, a negative pregnancy test taken within the past week is required before registration.Your hemoglobin level must be at least 9 g/dL in the preceding three weeks before registering.You are willing to return to the enrolling institution for follow-up assessments during the monitoring phase of the study.My tumor is in the brain stem, midbrain, or thalamus.Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase levels are within 3-fold of the upper limit of normal, with bilirubin concentration being no greater than 2.5 mg/dL in the preceding three weeks before registration.Your prothrombin time is less than or equal to 1.5 times the upper limit of normal within 3 weeks preceding registration.I have been treated with bevacizumab before.You are willing to give blood samples for associated research.I am willing to give tissue samples for research.I've had surgery, radiation, and chemotherapy with temozolomide for my condition.Your platelet count must be at least 100 x 10^9/L within the past three weeks.I am between 18 and 65 years old.I can care for myself but may need occasional help.I am willing to have a device implanted for CSF sampling for research.I am only having a biopsy or cannot have surgery.There is a quantifiable pathology according to the iRANO criteria.Your serum creatinine and urea levels are within twofold of the upper limit of normal range in the last three weeks.You have an absolute neutrophil count of 1.5 x 10^9/L or higher within the last three weeks.You are capable of comprehending and providing written and verbal agreement to the protocol.Your INR and PTT levels are not more than 1.5 times the upper limit of standard values (within 3 weeks before enrollment).I have a GBM diagnosis with a recurring tumor at the same spot and am set for another surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AMSCs)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA rendered its verdict on Autologous Mesenchymal Stem Cells (AMSCs) as an acceptable treatment?
"Taking into account the limited data related to Treatment (AMSCs) in Phase 1 trials, our team at Power estimates its safety level as a 1."
Answered by AI
Am I eligible to enroll in this clinical research study?
"Those who hope to be accepted into this clinical trial must have a diagnosis of glioblastoma, and their age should fall between 18-65. The research team is looking for approximately 20 participants in total."
Answered by AI
Is this research program recruiting individuals aged fifty and above?
"This trial can only accept applicants between the ages of 18 and 65. Those younger or older must look for other trials, as there are 190 studies available for those under 18 and 1257 options open to those over 65 years old."
Answered by AI
Are researchers currently inviting participants to join this scientific experiment?
"According to the records stored on clinicaltrials.gov, this medical research is not currently recruiting participants; it was initially published 28th March 2023 and last updated 16th March 2023. Despite no longer being open for enrolment, 1,412 other trials are actively enrolling patients at present."
Answered by AI
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