Clinical trial NCT03929120: Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interstitial Lung Disease
Connective Tissue Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Adverse Events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Andy Abril, MD
role: PRINCIPAL_INVESTIGATOR
References: