About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)

Clinicaltrials.gov identifier NCT03929120

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted August 25, 2020

Study Description

Brief summary:

Researchers are trying to find out more about the safety of a new treatment, Allogeneic (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) which is still experimental, for Interstitial Lung Disease (ILD) associated with Connective Tissue Disorder (CTD).

  • Condition or Disease:Interstitial Lung Disease
    Connective Tissue Diseases
  • Intervention/Treatment: Biological: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase I Study to Evaluate the Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for Interstitial Lung Disease in Patients With Connective Tissue Disorders
  • Actual Study Start Date: November 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Interstitial Lung Disease with Connective Tissue Disorder
Subjects with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorder (CTD) will receive a new treatment called Allogeneic (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
Biological: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
Subjects will be treated with regular standard of care plus 0.5-1 million MSC/Kg intravenously.
Outcome Measures
  • Primary Outcome Measures: 1. Adverse Events [ Time Frame: 6 months ]
    Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose
Eligibility Criteria
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Adults over 18 years of age and less than 80 years of age

- Both female and male

- Patients with new diagnosis of interstitial lung disease associated with connective
tissue disorders, Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitis
or idiopathic pneumonia with autoimmune features (IPAF) or established diagnosis of
ILD associated with CTD under conventional therapy for at least 6 months but less than
24 months, with no evidence of improvement.

- Competent and able to provide written informed consent, and ability to comply with
protocol

Exclusion Criteria:

- Patients with interstitial lung disease without evidence of a concomitant
rheumatologic autoimmune disorder

- Exposure to rituximab or cyclophosphamide on the previous 2 months

- Severe interstitial lung disease defined by the presence of severe hypoxemia at rest
(SO2 < 88% at rest) - Clinical assessment that indicates active chronic infections such as osteomyelitis or active tuberculosis (TB), or acute infections such as pneumonia, active bronchitis, cellulitis, etc. or active solid tumors or hematologic malignancies - Previous treatment with mesenchymal stem cells - Clinically significant medical conditions within the six months before administration of BMD-MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. - Medical history of human immunodeficiency virus (HIV), Hepatitis B or C - Abnormal complete blood count (CBC), creatinine, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) at screening - Pregnant or breast feeding - Unwilling to agree to use acceptable contraception methods during participation in the trial - Inability to provide informed consent

Contacts and Locations
Contacts

Contact: Laura Akhtar (904) 953-9648 Akhtar.laura@mayo.edu

Locations

United States, Florida
Mayo Clinic in Florida
Jacksonville

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Andy Abril, MD Mayo Clinic

More Information
  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03929120 History of Changes
  • Other Study ID Numbers: 18-007216
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: August 25, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lung Diseases
    Lung Diseases, Interstitial
    Connective Tissue Diseases