Post
COVID-19 Treatment

Cord tissue-derived MSCs (Mesenchymal Stem Cells), have been shown to improve post-acute COVID-19 symptoms by significantly decreasing inflammatory cytokines, modulating the immune system and improving recovery times.

POST-ACUTE COVID-19 SYNDROME DETAILS

Can stem cells help?

Post-acute COVID-19 syndrome explained.

Similarly to post-acute viral syndromes described in survivors of other virulent coronavirus epidemics, there are increasing reports of persistent and prolonged effects after acute COVID-19. Patient advocacy groups, have helped contribute to the recognition of post-acute COVID-19, a syndrome characterized by persistent symptoms and/or delayed or long term complications beyond 4 weeks from the onset of symptoms.

Mesenchymal Stem Cell Therapy for COVID-19

Since the COVID-19 pandemic began there have been many studies conducted that aim to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC‐MSC) infusions in subjects with COVID‐19. Mesenchymal stem cells administered intravenously may be able to significantly reduce significant adverse reactions, mortality, and time to recovery, in COVID-19 patients.

Treatment goals

The therapeutic uses of stem cells as a potential therapy for a variety of diseases has been immensely explored, the number of clinical trials conducted with Mesenchymal Stem Cells has increased exponentially over the past few years.

The stated primary goal of our protocol is the marked reduction in the levels of chronic low-grade inflammation for an extended period of time.

Stem cells have a unique, intrinsic property that attracts them to inflammation in the body. Studies have shown that stem cells can regenerate damaged or diseased tissues, reduce inflammation and modulate the immune system promoting better health and quality of life.

In regards to post-acute COVID-19 syndrome, patients can expect fewer long term complications, improved recovery time, a reduction in persistent COVID-19 related symptoms & an overall decrease in inflammation throughout the body.

Benefits of Mesenchymal Stem Cells (MSCs)

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Decrease Inflammation

UC-MSC treatment can significantly decrease inflammatory cytokines involved in the COVID-19 "cytokine storm."

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Improve Patient Survival & Recovery Time

UC‐MSC treatment can be associated with significantly improved patient survival and time to recovery.

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Safe Treatment

Intravenous infusion of umbilical cord mesenchymal stem cells (UC‐MSCs) are safe in COVID‐19 patients with acute respiratory distress syndrome. (View study)

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Fewer Complications

This double blind randomized controlled trial in 24 subjects demonstrated fewer serious adverse events in the UC‐MSC treatment group compared with the control group.

Minimally Invasive Treatment

Improve Bodies Natural Healing Ability

Patients Report Significant Improvement

Timely, Safe, Regulated Protocol

Critically ill COVID-19 Patient Successfully Treated with Mesenchymal Stem Cells

Abstract

Our partner lab Vitro Biopharma received emergency use authorization from the FDA to treat a critically ill COVID-19 patient with mesenchymal stem cells in the United States.

Patient History

This patient was admitted to an emergency room with classic COVID-19 symptoms in late April and had several comorbidities prior to admission. While intubated in the intensive care unit (ICU), the patient’s condition worsened using the standard of care and treatment with convalescent plasma. The patient’s kidney and liver function began to fail, requiring dialysis. Additionally, the patient experienced sepsis and a stroke while in the ICU and was comatose for almost 7 weeks.

Treatment Results

Following the treatment the patient experienced resolution of multiple organ failure, recovery from coma, and restoration of neurological, pulmonary, liver and renal function. The patient was removed from assisted respiration and dialysis. The patient now eats, drinks, speaks, and has regained motor function. Measures of inflammation that were elevated at admission and rose during ICU treatment, returned to normal levels. The patient has recently been discharged from ICU and is currently undergoing physical therapy to recover from the stroke suffered while in the ICU.

“We are pleased to have achieved this milestone that was based on thorough understanding of the science of stem cell biology,” said Dr Jim Musick, CEO of Vitro Biopharma.

“While regeneration of destroyed cells is a common effect of stem cell therapy, stem cells also regenerate damaged cells by various regenerative processes that restore normal organ function. The results of this case support the further study of mesenchymal stem cell therapy for COVID-19 patients and other conditions characterized by acute respiratory distress that are ultimately related to the inflammatory cytokine cascade that is neutralized. Our stem cell product appears to have a significant therapeutic application in treatment of multi-organ failure related to COVID-19 infections.

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Viability

All of our cells are tested to International Society Cell & Gene Therapy (ISCT) standards for viability to ensure they meet minimum QA requirements multiple times before treatment. These reports can be provided to the patient for their review upon request.

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Quality Control

Cells are rigorously tested for potency, blood-borne pathogens, contaminating agents, fungal presence, cellular ATP levels, and proper growth rates. The entire production process is completed in a certified sterile clean room, which must meet all regulations by the FDA, ISO, and CLIA.

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Safety

Cord-tissue derived mesenchymal stem cells do not face immune rejection within the body. These are primal, immune-privileged, undifferentiated cells. There are no blood products associated with them either, removing the need for a donor match; they are accepted universally.

Why use cord tissue derived stem cells?

Umbilical cord tissue is a natural bi-product of child birth, but also rich in mesenchymal stem cells which can be used to help heal, regenerate, and treat a variety of conditions.

Cord-tissue derived mesenchymal stem cells do not face immune rejection within the body. They are youthful, immuno-privileged, undifferentiated cells that have yet to be “claimed.” There are also no blood products associated with them, removing the need for HLA matching; cord tissue derived mesenchymal stem cells are universally accepted.

Recent studies have shown that although stem cells can be found in every living person, their numbers and potency can diminish with age. Additionally, cells sourced from the tissues of those patients with autoimmune/degenerative conditions may contain components of those disorders, detracting from the effectiveness of their use in treatments. Cord tissue derived stem cells bypass both of these issues, while remaining minimally invasive to the patient, and always available for immediate use.

FDA Registered Facility
Clinical Laboratory Improvement Amendment
ISO Certification
ISO Certification

Learn more about our partner lab Vitro Biopharma here

Giacomo Lanzoni, et al.

Umbilical cord mesenchymal stem cells for COVID‐19 acute respiratory distress syndrome: A double‐blind, phase 1/2a, randomized controlled trial

Abstract

This study was a double‐blind, randomized, controlled, early phase clinical trial of umbilical cord mesenchymal stem cell treatment in 24 subjects with COVID‐19 acute respiratory distress syndrome. This study demonstrated fewer serious adverse events in the treatment group compared with control. Exploratory efficacy analyses provide evidence of significantly improved patient survival and time to recovery. The observed findings strongly support further investigation in a larger trial designed to estimate and establish efficacy. These observations will inform physicians influencing clinical practice and future research in the fields of acute respiratory distress syndrome, COVID‐19, and other immune‐related disorders.

Primary Endpoints

• Two intravenous infusions of umbilical cord mesenchymal stem cells (UC‐MSCs), at a dose of 100 million cells per infusion, given 72  hours apart, are safe in COVID‐19 patients with acute respiratory distress syndrome.

• This double blind randomized controlled trial in 24 subjects demonstrated fewer serious adverse events in the UC‐MSC treatment group compared with the control group.

• UC‐MSC treatment was associated with a significant decrease in a set of inflammatory cytokines involved in the COVID‐19 “cytokine storm.”

• UC‐MSC treatment was associated with significantly improved patient survival and time to recovery.

Conclusion

This double-blind randomized, controlled clinical study found that mesenchymal stem cells were successfully used to treat COVID-19 patients. We can utilize this information to showcase the potential of mesenchymal stem cells to improve post-acute COVID-19 symptoms that seem to persist over a course of months following initial infection.

The reduction of inflammation and immunomodulatory effects of mesenchymal stem cells can positively influence ones immune response. This can inhibit the harmful "cytokine storm" that occurs within the pulmonary system post COVID-19 infection.

Reference

1) Lanzoni, G., Linetsky, E., Correa, D., Cayetano, S., Alvarez, R., Kouroupis, D., . . . Ricordi, C. (2021, January 05). Umbilical cord mesenchymal stem cells for COVID‐19 acute respiratory Distress syndrome: A DOUBLE‐BLIND, phase 1/2a, randomized controlled trial. Retrieved March 26, 2021, from https://stemcellsjournals.onlinelibrary.wiley.com/doi/10.1002/sctm.20-0472

Figure 1.

Kaplan‐Meier curves. A, Survival. At 31 days after the first infusion (corresponding to 28 days after the last infusion), patient survival was 91% vs 42% in the UC‐MSC and control group, respectively (P = .015). The difference between the groups was statistically significant. B, SAE‐free survival. SAE‐free survival was significantly improved in the UC‐MSC treatment group compared with the control group (P = .008). SAEs affected two vs eight patients in the UC‐MSC and control group, respectively. C, Time to recovery. Time to recovery was significantly shorter in the UC‐MSC treatment group compared with the control group (P = .031). Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was considered censored at the end of study observation; thus the patient conservatively remained in the risk set for all Kaplan‐Meier estimation throughout the study period. CI, confidence interval; HR, hazard ratio; SAE, serious adverse event; UC‐MSC, umbilical cord mesenchymal stem cell (1)

1

IRB Approved Protocol

2

Day Treatment

300

Million MSCs

10+

Years of Stem Cell Experience

TREATMENT SCHEDULE

Learn more about our treatment.

2-day non-invasive treatment

Our treatment consists over a two-day period which includes the systemic intravenous (IV) transplant of 300 Million cord tissue-derived MSCs, as well as a variety of therapies designed to aid stem cell activation. The procedure is minimally invasive (single IV transfusion) and has very little downtime. Most patients are able to travel the day after treatment.

1

Day One

Arrival in Grand Cayman.

2

Day Two

Meet the team, complete physical assessments & supporting therapies.

3

Day Three

Stem cell transplant & additional activation therapies.

4

Day Four

Follow-up physical & departure.

Additional stem cell activation therapies

Our protocol utlizes additional therapies prior to and post-treatment to help activate natural stem cell production within the body. We aim to position the patient into an optimal state to receive the influx of new stem cells.

The supporting therapies that are included in our protocol are:

• Musculoskeletal Assessment
• Physiotherapy Treatment
• Immune Balancing Acupuncture
• Lymphatic Drainage Massage
• IV Vitamin Therapy

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Da Vinci Centre, Cayman
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OUR CLINIC

Learn more about our clinic.

About

DVC Stem is located in Grand Cayman, a small island paradise in the Caribbean. As a British Overseas Territory, healthcare regulations are extremely strict, on par with the US, UK, and EU. Additionally, our entire medical staff is fully registered and licensed, and our stem cell protocols are IRB reviewed and approved by a board in the United States. The Cayman Islands is a safe, English-speaking British Overseas Territory and hosts over 2 million tourists a year.

There are many direct flights to Grand Cayman from major cities in the United States, Canada and Europe. DVC Stem is located within the Da Vinci Centre a large modern medical facility directly on Seven Mile Beach.

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Clinic Highlights

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Highly Regulated

As a British Overseas Territory, healthcare regulations are extremely strict, on par with the US, UK, and EU.

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US Sourced Stem Cells

DVC Stem is partnered with Vitro Biopharma, an award-winning medical laboratory located in Golden, Colorado, which is fully FDA registered, cGMP compliant, ISO 9001, and ISO 13485 certified.

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Experienced Medical Staff

Every patient is under constant supervision by our Medical Director and two registered nurses.

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Dedicated Patient Success Team

Our patient management team will happily guide you through the onboarding process.

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Beautiful Location

Our clinic is located directly on the world famous Seven Mile Beach, one block away from the Ritz Carlton Resort.

UNDERSTANDING TREATMENT GOALS

Measuring treatment results.

"We measure inflammation markers and telomere length both pre and post treatment. We also follow up with patients at 3, 6, 9 and 12 month mark intervals with vitality questionnaires. These are extremely important because they enable us to measure patient satisfaction in relation to treatment efficacy."

- Louis A. Cona, MD

Treatment results

We only offer treatments for conditions that have medical research backing positive results and no harmful side effects. Dozens of studies have shown the efficacy of stem cell therapies for various degenerative diseases, and we have had great success from our past patients. Patients normally experience an increase in mobility, sensation, balance, strength, & energy along with a reduction in stress and pain levels.

However, it is impossible to guarantee any specific result for an individual, as every person’s body is unique and will respond in different ways.

Our re-treatment protocol

Our official treatment protocol does not require that patients repeat treatment. Our goal is to help manage symptoms and slow progression, so that our patients won't have to return. To date, we have had no patient reports of a worsening of their condition within 1 year of treatment.

Approximately 82% of first-time patients report a significant improvement in their condition within the first 6 months following their treatment date.

Frequently asked questions

What type of stem cells does DVC Stem use?

We administer over 300 million cord tissue-derived mesenchymal stem cells. DVC Stem is partnered with Vitro Biopharma, an award-winning medical laboratory located in Golden, Colorado, USA, which is fully FDA registered, cGMP compliant, ISO 9001, and ISO 13485 certified. Cells are only sourced from the American Association of Tissue Bank (AATB) certified suppliers of full-term, ethically US donated human umbilical cords. The selection of these donated tissues is extremely regulated and strict. All of our cells are expanded using safe and standard protocols and are then flown overnight in sub-zero containers directly to our clinic for immediate treatment. To ensure maximum treatment effectiveness, our cells are expanded to as much as 300 million cells before being administered.

What are mesenchymal stem cells?

Stem cells are cells that have the ability to become many different cell types in the human body.  Stem cells have the ability to replace damaged or diseased tissue. Mesenchymal cord tissue-derived stem cells have an extremely high rate of differentiation and immune modulation.  MSCs (Mesenchymal Stem Cells) can provide regenerative results through seeking out areas of damage, paracrine signalling, regulating immune responses, and positively affecting human microbiology. MSCs are also immune privileged meaning the body will not reject them.

Why should I travel abroad for treatment?

Despite the overwhelmingly positive clinical evidence, the United States still has very strict regulations and laws against stem cell treatments. While you may find many clinics in the US offering “stem cell therapies”, these therapies are highly restricted in scope and number of cells used. It is currently not legal to obtain expanded allogeneic treatment inside the US. The expansion is what allows the high cell numbers needed for effective treatment. DVC Stem seeks to provide patients with safe and effective treatments, in a luxurious and beautiful setting.

DVC Stem is located in the beautiful island paradise of Grand Cayman. We are only a short 45 minute flight from Miami & our clinic is situated directly across from the world famous Seven Mile Beach.

What makes DVC Stem different from other clinics?

It is important to note that DVC Stem sources cells from a FDA registered, cGMP compliant, ISO 9001, and ISO 13485 certified lab in the United States. This means that the patient receives only the highest quality, regulated mesenchymal cord tissue-derived stem cells. We are highly regulated by the Cayman Islands government, and legally able to provide expanded cell therapy.

When looking for a reputable stem cell therapy clinic it is important to ask them; where their cells come from, how many cells you will receive and what sort of treatment protocol they follow. It is important to note that under-regulated clinics can extract stem cells from a variety of sources, not all of which are safe & effective.

What type of results should I expect?

We only offer treatments for conditions that have years of medical research backing positive results with harmful side effects. Dozens of studies have shown the efficacy of stem cell therapies for various degenerative diseases, and we have had great success from our past patients.

Our stem cell therapy aims to regenerate degraded tissue, modulate the immune system, promote anti-inflammatory mechanisms and improve overall quality of life.

Patients have reported improvements in energy levels, mobility, strength, balance, symptom management and aesthetics.

How do I begin the treatment process?

We require all prospective patients to fill out our patient application form. This will allow our medical director to better understand your candidacy for treatment as well as what you hope to achieve with stem cell therapy. Once this has been completed you will receive an email with further instructions. If you are ready to begin the process you can apply for treatment here.

ONBOARDING PROCESS

Pre-treatment protocol

We require patients complete a pre-treatment lab / exam panel

As per the requirements set forth by the Cayman Islands Government, our protocol is required to be IRB reviewed, approved, and audited for compliance on a 6 month basis.

We require that all patients complete a pre-treatment lab / imaging / exam panel prior to being cleared for treatment.

The tests required serve both to establish baseline values pre-treatment for things like inflammatory markers, as well as test for infections and cancers, both of which may jeopardize the safety of the patient.

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Our requirements

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Highly Regulated

As a British Overseas Territory, healthcare regulations are extremely strict, on par with the US, UK, and EU.

1

Initial Screening

The initial screening application will allow us to determine if you are a good candidate to begin the pre-treatment process. Most applications will receive a response within 24 hours.

2

Intake Forms

f accepted you will receive a link to complete your medical history forms. Once completed you will receive a list of labs / exams that must be completed prior to treatment.

3

Packet Review

Once your forms, medical history, and labs / exams have been submitted for review, our medical team may provide final clearance.

4

Schedule Treatment

Once approved, you may book your treatment on your desired date, subject to availability.