Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

June 13, 2017 updated by: Aliae AR Mohamed Hussein, Assiut University

Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis

Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our disappointment, pulmonary and critical care medicine have traditionally lagged behind other therapeutic and research fields including hematology, gastroenterology and cardiology in translational studies of the use of reparative cells

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 75 years (both inclusive)
  • high-resolution computed tomography (HRCT) scan that is very suggestive or consistent with a probable diagnosis of usual interstitial pneumonia.
  • Bronchoalveolar lavage must be performed at any time before inclusion and must have failed to show features supporting alternative diagnoses.
  • The duration of the disease should be more than three months, and bibasilar inspiratory crackles should be present.
  • dyspnea score of at least 2 on a scale of 0 (minimum) to 10 (maximum).
  • FVC > 50% of the predicted normal value and DLco > 35% of the predicted value.
  • Patients under treatment with n-acetylcysteine or pirfenidone should discontinue drug and enter a wash-out period for at least 6 weeks prior study enrolment.

Exclusion Criteria:

  • FVC < 50% predicted normal value and DLCO < 35%predicted normal value.
  • lung cancer or with an evidence of active malignancyfor at least 5 years.
  • uncontrolled heart failure.
  • renal failure
  • hepatic failure,
  • neurological abnormalities including stroke and myasthenia Gravis
  • Anti-coagulants therapy.
  • Active infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IPF patients
autologous bone marrow mesenchymal stem cells
Biological: autologous bone marrow mesenchymal stem cells
intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
Time Frame: 6 months
safety and side effects
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post therapy diffusing capacity of CO% (DLCO)predicted
Time Frame: 6-12 months
Efficacy of procedure
6-12 months
post therapy forced vital capacity (FVC)% predicted.
Time Frame: 6-12 months
efficacy of the procedure
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 11, 2017

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (ACTUAL)

June 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stem Cell Transplant Complications

Clinical Trials on autologous bone marrow mesenchymal stem cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe