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The Pandemic Predicament

A New Priority: COVID-19

March 5, 2020, Hope Biosciences Stem Cell Research Foundation celebrated its grand opening. The foundation was the culmination of people coming together with a common vision: to revolutionize the way we treat disease and injury. We presented a long list of projects we would love to fund but as it turns out, a pandemic was on the horizon. We quickly shifted gears and our focus led us face to face with the virus.

Today, we are leading the effort in using stem cells to combat COVID-19. With three FDA approved protocols for coronavirus, we will be executing these trials as quickly and as efficiently as possible. Join us in the journey.

34300000000
Stem Cells Made for COVID-19
255
Total Participants Expected
200
Treatments Completed
IMAGE SOURCE: National Institute of Health (NIH)
HBCOVID-01

Autologous Mesenchymal Stem Cells to Provide Immune Support Against COVID-19

Study Description

This Phase II study is a single arm, non-randomized study that is expected to enroll 55 participants that are either 50 years of age, have preexisting health conditions, or are at high-exposure risk. The study’s primary objective is to determine the efficacy of HB-adMSCs to prepare the immune system so that it is better able to fight the virus, should one become infected. We anticipate that this pretreatment will limit the progression and severity of COVID-19, ultimately keeping patients out of the hospital and off of mechanical ventilation. HB-adMSCs are administered via five intravenous infusions over a fourteen-week period and follow-up evaluations through 6 months. All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

Protocol Details

Participants
55
Schedule
5 Treatments at 0, 2, 6, 10, 14 Weeks
Duration
26 Weeks
Start Date
April 22, 2020
Projected End Date
December 21, 2020
Status
Enrollment Complete

What We're Measuring

All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

What We're Expecting

In a recent Phase I/II clinical trial for rheumatoid arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating systemic inflammation. In COVID-19 patients, inflammation is a driving force behind disease progression, and interceding early in the inflammatory process will give us the best possible outcome. Our expectation is that participants will not develop a serious case of COVID-19.

Your support makes this possible

Data unavailable at this time.
HBCOVID-02

Allogeneic Mesenchymal Stem Cells for Frontline Workers to Provide Immune Support Against COVID-19

Study Description

This Phase II study is a randomized, placebo-controlled, double-blind, single center study that is expected to enroll 100 frontline healthcare workers and first responders. The study’s primary objective is to determine the efficacy of HB-adMSCs to provide immune support against COVID-19. Participants will be randomly sorted into one of four groups, placebo, 50 million cells/dose, 100 million cells/dose, or 200 million cells/dose. HB-adMSCs or placebo will be administered intravenously for a total of 5 infusions over a 14-week period. Assessments will be performed prior to each infusion and at 26 weeks to end the study.

Protocol Details

Patient Population
100
Schedule
5 Treatments at 0, 2, 6, 10, 14 Weeks
Duration
26 Weeks
Start Date
May 14, 2020
Projected End Date
December 2020
Status
Enrolling

What We're Measuring

All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

What We're Expecting

We expect providing HB-adMSC therapy will boost the immune system, especially in cases of individuals at high-risk of developing COVID-19. A healthy immune system is better able to defend against infectious agents like SARS-CoV-2 and decreases the chance a patient will become critically ill. This not only helps keep people healthy, but it decreases the tremendous burden already on a stressed healthcare system. With this treatment, we hope to build a line of defense for our most vulnerable.

Your support makes this possible

Please submit your inquiries below.

Thank you for your interest in participating in our clinical trial! This protocol is specifically designed for frontline healthcare workers and first responders - those at high risk for contracting COVID-19. It is our hope and expectation that this theray will provide immune support against the virus. After submitting this form, a member of our trial staff will contact you within 24 hours.

The following information is required and used to segment our participants in our randomized study.

* — These fields are required

If you experience issues using the above sign-up form or prefer to talk to one of our associates, please contact us at +1 832 975 8840 or email us at support@hopebio.org. Thank you!



Data unavailable at this time
HBCOVID-03

Allogeneic Mesenchymal Stem Cells to Treat Hospitalized Patients Affected by COVID-19

Study Description

This Phase II study is a randomized, placebo-controlled, double-blind, single center study that is expected to enroll 100 patients suspected to have COVID-19 into 2 separate arms, receiving either placebo or HB-adMSCs. This will serve as a supplement to the standard of care provided to address the infection. Those receiving treatment will receive 4 doses of 100 million HB-adMSCs over a 10-day period.

Protocol Details

Participants
100
Schedule
4 Treatments Over 10 Days
Duration
28 Days
Start Date
May 2020
Projected End Date
December 2020
Status
Enrollment Begins Soon

What We're Measuring

All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

What We're Expecting

Mesenchymal Stem Cells, MSCs, are well-known for their immunomodulatory and regenerative potential. These characteristics make them a potential therapeutic option to fight the inflammation that is known to occur in symptomatic COVID-19 patients. We expect patients suffering symptoms associated with COVID-19 will have the opportunity to receive HB-adMSCs, in addition to current standard of care. The data generated in this study will determine the role HB-adMSCs may play in decreasing the severity of illness from COVID-19 infection. HB-adMSC treatment may decrease the severity of symptoms and limit disease progression, ultimately decreasing mortality rate.

Your support makes this possible

Data unavailable at this time

Thank you to these organizations joining us in the fight against COVID-19