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Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD

NCT02161744 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-01-27

No results posted yet for this study

Summary

The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients with chronic obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control baseline of 6 weeks.

Patients will be followed up for 12 months after the therapy.

Conditions

Interventions

BIOLOGICAL

ADSCs administration

100- 240 cc of lipoaspirate will be extracted from the patient. The stromal vascular fraction (SVF) will be isolated with minimal manipulation. The cell pellet will be reconstituted in saline solution and administered intravenously to the patient.

Sponsors & Collaborators

  • Arkansas Heart Hospital

    lead OTHER

Principal Investigators

  • Jason Holder, MD · Arkansas Heart Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-10
Primary Completion
2018-10-29
Completion
2018-10-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161744 on ClinicalTrials.gov