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

NCT01559051 | Withdrawn Phase 1

• 1 other identifier: AD-US-COPD-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Pulmonary; Lungs

Outcome Measures

Primary Outcomes (2)

• Functional Capacity improved compared to baseline

  6 Minute Walk Test

  3 months, 6 months

• Number of adverse events

  3 months, 6 months

Secondary Outcomes (1)

• Quality of Life improved compared to baseline

  3 months, 6 months

Study Arms (1)

Intravenous Injection and Inhalation infusion of AD-SVF

EXPERIMENTAL

AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation

Procedure: Lipoaspiration with Local anesthesia

Interventions

Lipoaspiration with Local anesthesia PROCEDURE

Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.

Also known as: Liposuction

Intravenous Injection and Inhalation infusion of AD-SVF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ageless Regenerative Institute: lead

Study Sites (1)

Ageless Regenerative Institute LLC

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Anesthesia, Local; Lipectomy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Sharon McQuillan, MD

  Ageless Regenerative Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: March 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2016-09

Locations

US (1)