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Stem Cell Therapy
Mesenchymal Stem Cells for COPD
Phase 1
Waitlist Available
Led By Jorge M Mallea, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour post completion of infusion
Awards & highlights
Study Summary
This trial is testing whether mesenchymal stem cells can help ease symptoms and improve quality of life for people with advanced COPD.
Who is the study for?
Adults with advanced COPD who've had a flare-up in the last year, have quit smoking for at least six months, and have specific lung function test results. They must not be pregnant or breastfeeding, have a history of certain diseases like cancer or autoimmune disorders, recent infections requiring antibiotics, or severe heart issues.Check my eligibility
What is being tested?
The trial is exploring the effects of mesenchymal stem cells on patients with advanced chronic obstructive pulmonary disease (COPD) to see if this therapy can improve their lung function and quality of life.See study design
What are the potential side effects?
While the side effects are not detailed here, similar therapies may cause immune reactions, infection risks due to stem cell infusion, potential tissue damage at injection sites and allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one hour post completion of infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour post completion of infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Side effects data
From 2020 Phase 1 trial • 14 Patients • NCT0286672133%
Myalgia
33%
Diarrhea
33%
Risk of Pathogen Exposure
33%
Non-cardiac Chest Pain
33%
Cough
33%
Vomiting
33%
Increased Sputum Production
33%
Abdominal Pain
33%
Change in Appetite
33%
Generalized Pain
33%
Lethargy
33%
Hypomagnesemia
33%
Syncope
33%
PICC Line Insertion
33%
Cystic Fibrosis Pulmonary Exacerbation
33%
Constipation
33%
PICC Line Right Upper Extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
1 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
3 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
5 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
Trial Design
1Treatment groups
Experimental Treatment
Group I: Subjects with Advanced Chronic Obstructive Pulmonary DiseaseExperimental Treatment1 Intervention
Subjects diagnosed with severe or very severe COPD will be infused intravenously with Mesenchymal Stem Cells (MSC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal Stem Cells
2016
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,845 Total Patients Enrolled
Jorge M Mallea, MD4.04 ReviewsPrincipal Investigator - Mayo Clinic
Mayo Clinic
5Patient Review
I don't think I could heap enough praise on Dr. Mallea. They have an incredible wealth of knowledge and they're amazing with patients. I really don't think I'd be alive if it weren't for them.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body is very overweight (BMI over 35) or very underweight (BMI less than 16).You have started a program to improve your lung function within the past 12 weeks.You have had cancer in the past or currently have cancer.You have a history of autoimmune disorders not related to COPD.You have had HIV, Hepatitis B, or Hepatitis C in the past.Your liver function tests show high levels of alkaline phosphatase, total bilirubin, ALT, or AST.You have a serious lung condition called bronchiectasis.You have not used any nicotine products for at least six months before joining the study.You must have at least a score of 2 on the modified Medical Research Council (mMRC) scale.You have had a serious worsening of your COPD in the past year that needed antibiotics or steroids.You have a serious illness that could make it hard for you to handle the treatment or finish the study.You have been diagnosed with a lung disease other than COPD, like asthma or pulmonary fibrosis.You have been diagnosed with α1-Antitrypsin deficiency.Your kidneys must work well enough to filter out waste from your blood.Your lungs must be able to hold at least 80% of the air they're supposed to.You used to smoke a lot, at least 10 packs of cigarettes a year.You have been hospitalized for a severe COPD flare-up within the last 12 weeks.You have taken a medication called prednisone or a similar type of medicine in the past 12 weeks.You have recently had a heart attack, unstable angina, or other serious heart problems, or have certain heart conditions or devices.You have had surgery to remove part of your lung or have had a lung transplant.You are taking medications that weaken your immune system.Your lung function test shows that you can breathe out a certain amount of air, but not too much or too little.You have advanced chronic obstructive pulmonary disease (COPD).Your lung function test shows a specific result called FEV1/FVC ratio that is less than 0.7 after using a bronchodilator.Your oxygen levels while resting in a regular room need to be 88% or higher.Your lung function test result must show that you can breathe out a certain amount of air, which is between 20% and 49% of what is expected for someone your age and size after using a bronchodilator.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with Advanced Chronic Obstructive Pulmonary Disease
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.
How many volunteers are participating in this medical trial?
"Affirmative. According to the information on clinicaltrials.gov, this clinical trial is still enrolling participants since its original posting date of June 1st 2020 and most recent update of May 1st 2022. 15 individuals need to be recruited from one site for participation in the study."
Answered by AI
Is there an opportunity for me to participate in this experiment?
"This trial seeks to enrol 15 individuals between 18 and 90 years old who are suffering from lung diseases. Besides the age requirement, applicants must have experienced an exacerbation of COPD within 12 months preceding enrollment into the study; a post-bronchodilator FEV1/FVC ratio below 0.7; a total lung capacity (TLC) with no less than 80% predicted value; at least 10 pack-years smoking history but also abstinence from nicotine products for 6 months prior to registration in the clinical trial as well as scoring 2 or more on modified Medical Research Council scale (mMRC)."
Answered by AI
Has the FDA granted approval for Mesenchymal Stem Cells?
"Due to limited data concerning efficacy and safety, our team at Power gave Mesenchymal Stem Cells a score of 1 on the scale of 1-3."
Answered by AI
Does this experiment admit participants who have surpassed their 50th birthdays?
"This clinical study adheres to the guideline that participants should be no younger than 18 and not exceed 90 years of age."
Answered by AI
Is enrollment for this experiment currently open?
"The clinicaltrial.gov website indicates that this research is actively seeking volunteers; the trial was published on June 1st 2020 and its details were last adjusted on May 1st 2022."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Alabama
Florida
How old are they?
18 - 65
65+
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Mayo Clinic in Florida: < 48 hours
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