Now Recruiting Patients for a New FDA Oversight Trial Evaluating the Use of a Patient's Own Fat Tissue for the Treatment of Post-COVID-19 Lung Damage

Nov. 17, 2020 11:00 UTC

Promising research leads to formal trial sponsored and funded by Tulip Medical.

(tulipmedical.com)

[NCT #04326036 an FDA Oversight Trial]

SAN DIEGO--(BUSINESS WIRE)-- Tulip Medical (a dba of Black Tie Medical, Inc.) has sponsored and funded a new FDA Oversight Trial that seeks to restore respiratory function in adults who have suffered lung damage from the COVID-19 virus. Robert W. Alexander, MD, DMD, FICS is the Principal Investigator, and his office is recruiting patients for enrollment in the trial. "We're building on two years of existing trials in patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and Farmer's Lung Disease (FLD)," says Dr. Robert W. Alexander, MD, DMD, FICS. "The existing clinical trials in lung disease using the body's own adult stem/stromal cells derived from fat have shown promising improvements as it relates to the gas exchange function that happens in healthy lungs. This is one of the common long-term effects on people who have contracted Coronavirus," explained Alexander.

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Alveolus in COVID-19 losing gas exchange capability (Graphic: Business Wire)

Alveolus in COVID-19 losing gas exchange capability (Graphic: Business Wire)

"The sterile, coated closed syringe microcannula systems and adipose processing solutions invented by Tulip Medical, San Diego, CA, USA, (the sponsor of the study) have proven to be among the most reliable and trusted systems available for the gentle, safe and easy access to these adipose cells and attachment media (ECM)," says Dr. Alexander.

"It is truly a pleasure to sponsor and fund this critical trial developed by Dr. Alexander," says Marcille Pilkington, Co-founder, President, and CEO of Tulip Medical. "Dr. Alexander's work thus far treating COPD and FLD patients who have run out of options is inspiring. Many of these patients, who have been told to get their affairs in order, experience improved lung function and quality of life after treatment. Logically, a similar protocol might be effective with lung damage in recovering COVID patients."

More information about the protocols and merits of the study, as well as the research that has led to the FDA's oversight of a patient trial, is available on the San Diego Academy of Regenerative Therapies (SDARTS.com) Online Learning Platform. The Panel discussion recorded on October 1, 2020, features Dr. Alexander and Dr. Ramon Llull, MD, Ph.D., a research colleague who has done extensive studies on the use of cellular Stromal Vascular Fraction (cSVF). "Fat contains cells with the intrinsic capacity of healing: the strength to mend scaffolds, bleeding vessels, and extinguish inflammation within the tissues," says Dr. Llull. "This will be of critical benefit for COVID-19 patients who have experienced scarring in the lungs. Based on our research, we are fairly confident that these therapies might be the answer to achieving compliant, healthy lungs." Tulip Medical is a subsidiary of SDARTs.

Patients considering participation in this clinical trial should email Dr. Alexander at irbtrials@gmail.com.

Watch the Panel Discussion Webinar with Dr. Alexander and Dr. Ramon Llull.

Read Dr. Alexander's newest article detailing the diagnostic and treatment protocol for this ground-breaking clinical trial in Stem Cell Research.

Read Dr. Llull's latest article characterizing adipose tissue's regenerative capabilities in the Journal of Plastic and Reconstructive Surgery.

Tulip Medical (tulipmedical.com) develops and markets innovative medical devices and systems for using adipose tissue (fat) for plastic surgery, dermatology, regenerative medicine, and anti-aging patient applications. Tulip holds numerous patents on medical devices and methods designed to help medical practitioners harness and deliver the benefits of fat to millions of patients.

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Contacts

For information about Tulip Medical, contact Debbie Pilkington, EVP, (Debbie@tulipmedical.com) at 858-270-5900.

 

Source: San Diego Academy of Regenerative Therapies

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