Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous and Inhalation Implantation of Autologous Adipose-Derived Stromal Vascular Fraction Cells in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01559051
• Other study ID #: AD-US-COPD-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 19, 2012
• Last updated: November 21, 2017
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the health of patients with human Chronic Obstructive Pulmonary Disease.

Description:

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.

The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• A prior diagnosis of moderate or severe COPD

• GOLD III and IV

• Age between 25 and 80 years

• Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria:

• Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study

• Life expectancy < 6 months due to concomitant illnesses.

• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.

• Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status

• Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

• Patients on chronic immunosuppressive transplant therapy

• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.

• Severe asthma that would contraindicate surgery

• History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.

• Unwilling and/or not able to give written informed consent.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Lipoaspiration with Local anesthesia
Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.

Locations

Country	Name	City	State
United States	Ageless Regenerative Institute LLC	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ageless Regenerative Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity improved compared to baseline	6 Minute Walk Test	3 months, 6 months
Primary	Number of adverse events		3 months, 6 months
Secondary	Quality of Life improved compared to baseline	St. George Respiratory Questionnaire	3 months, 6 months