BHI Therapeutic Sciences Inc. Notified by FDA that it can proceed with New Drug Clinical Trial for Acute Ischemic Stroke
BHI Therapeutic Sciences (BHITS), a leader in stem cell therapy and research utilizing human umbilical cord blood, announced today that the company has been notified by the Food and Drug Administration (FDA) that its Investigational New Drug (IND) application to allow for the initiation of a clinical study of an FDA-approved cell therapy (HCP, cord blood) for treatment of acute ischemic stroke may proceed.
Phase 1/2 Study entitled “Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects with Acute Ischemic Stroke” is a prospective, open-label, single-center, exploratory clinical study that is designed to characterize the safety and efficacy profile of HCP, cord blood, when administered by intravenous infusion and intrathecal injection, in 10 subjects who have sustained an acute ischemic stroke.
“Stroke is a leading cause of adult disability worldwide and the second highest cause of death in the world. To date, there are no clinically effective pharmacotherapies that can promote cellular functional recovery after an ischemic stroke. Human umbilical cord blood cell therapy is a promising treatment for ischemic stroke,” said Brian Mehling, M.D., chief medical officer of BHITS. “Stem cell therapy is an exciting, innovative method for the management and treatment of multiple medical conditions. We offer a unique concept that combines treatment and research,” he added.
BHITS will support other follow-on indications using umbilical cord derived stem cells for treatment of traumatic brain injury, including chronic traumatic encephalopathy. Chronic Traumatic Encephalopathy is a neurodegenerative disease that is found in people with multiple head injuries. It afflicts players in the National Football League. NFL players have committed suicide as a result of the disease. The NFL has set aside nearly $800 million to treat it, but there is currently no treatment. BHITS will also be approaching the NHL and their player’s union. BHITS intends to develop human umbilical cord-derived mesenchymal stem cell product based therapies for use in IND Phase 1 clinical trials in order to extend lifespans and improve the quality of life for patients.
In collaboration with local partners in Slovakia and China, BHITS’ sister company, Blue Horizon International has conducted several clinical investigations. Research subjects with chronic inflammation, musculoskeletal conditions, stroke and spinal cord injury were enrolled in our research studies and successfully treated with the application of human umbilical cord blood cells. In Slovakia, we are working on new clinical protocols (Parkinson’s disease, retinal and optic nerve diseases etc.) and planning to enroll research subjects in our existing and new research studies.
Dr. Mehling’s research has been published in both national and international scientific journals including International Journal of Medical, Health, Biomedical, Bioengineering, and Pharmaceutical Engineering and Stem Cell Research and Therapy.
August 2, 2018 BHI Sciences
BHI Therapeutic Sciences attended the World Economic Forum in Davos, Switzerland.
The 2018 World Economic Forum (WEF) in Davos explored the ideas, innovations and discoveries that are reshaping our world by working closely with those in the vanguard of change from such fields as the arts, culture, engineering, media, medicine, science, and technology.
During the past few days, the US-based company BHI Therapeutic Sciences (BHITS)
represented by Brian Mehling, MD, Founder and Chief Medical Officer; Klara Doert,
President of International Business Development; Katarina Novakova, Director of
Relations; and Manuel McDonald, International Consultant attended the annual meeting and participated in conversations, networking events, and attended sessions and panel discussions. This is the sixth year, the organization sent representatives to the meeting.
Dr. Mehling and his team have met with H.R.H. Crown Prince Haakon of Norway,
Founder of Global Dignity; H.R.H. Crown Princess Mette-Marit; Kofi Annan, former Secretary-General of the United Nations and co-recipient of the 2001 Nobel Peace Prize; Malcolm Stevenson “Steve” Forbes Jr., Editor-in- Chief of Forbes Media; Moira Forbes, EVP at Forbes Media/ Publisher, Forbes Woman; singer, songwriter, dancer and actor Usher; and many CEO’s, Fortune 500 companies C-level executives and government representatives.
BHITS has a treatment and research facility in Bratislava, Slovakia, as well as clinic
facilities in Wuhan, China and Jamaica. The medical team has already successfully
performed 3000 stem cell treatment procedures on more than 1000 patients.
BHITS has conducted several clinical studies testing the safety and efficacy of human umbilical cord blood (hUCB) stem cells. Our clinical studies have provide support for the short and long-term safety of hUCB stem cells for therapy of different medical conditions, including chronic inflammation, musculoskeletal conditions, stroke and spinal cord injury. Our intent is to develop hUCB product based therapies in Investigational New Drug Phase 1 clinical trials in order to extend lifespans and improve the quality of life for patients.
Dr. Mehling explained what stem cells could mean to global health, and how it is creating a future in which many chronic conditions and diseases will be managed with stem cells rather than allopathic medicine or traditional medicine.
“Stem cell treatments are, without a doubt, the future of medicine.” Dr. Mehling states. “It is very important that people making decision on what direction the world will take in regards to research and medical treatments, are educated about not only the possibilities in stem cell research but also about all the treatments that are already available for many patients with different chronic conditions, ” he added.
“By strategically placing our clinic in Slovakia, the heart of Europe, the most innovative research and treatments within the stem cell field is available for the global markets, just 45 minutes away from Vienna International airport, “ said Ms. Novakova.
The theme of this year’s meeting was “Creating a Shared Future in a Fractured World.” It was the first time that the forum's annual meeting featured an all-female panel of co-chairs.
Indian Prime Minister Narendra Modi listed his three most significant challenges to
civilization as we know it: climate change, terrorism and the backlash against
Norwegian PM Erna Solberg called for a focus on corruption and illegal money flows and asked for action on gender equality. “Education is the first step”, she said,” making sure that girls take a full part in education.”
BHI Therapeutic Sciences is pioneering ethical, effective, safe and affordable stem cell treatment therapies utilizing cord blood stem cells (those that are harvesting from an umbilical cord in the case of a C-Section, bringing no injury or risk to mother or baby).
Stem cells are a special kind of cell that can be used to regenerate the human body
without drugs or surgery, treating the leading diseases and injuries shortening our life spans and causing millions of people to live in chronic pain.
August 2, 2018 BHI Sciences
Stem Cells: The Next Frontier documentary screening for investors in NYC.
BHI Therapeutic Sciences (BHITS) and Brian Mehling, M.D. hosted a private screening of Stem Cells: The Next Frontier on Tuesday, February 13 in New York. The evening included a Q & A session and information on how to participate by becoming an investor to make these life-saving stem cells therapies more accessible to patients across the globe.
“At BHITS, our philosophy is that stem cells are the future of medicine and we are excited to share our ideas with the general public and investors. BHITS is pioneering ethical, effective, safe and affordable stem cell treatment therapies utilizing cord blood stem cells (those that are harvested from an umbilical cord in the case of a C-Section, bringing no injury or risk to mother or baby),” said Dr. Mehling. “Stem cells are a unique kind of cell that can be used to regenerate the human body without drugs or surgery, treating the leading diseases and injuries shortening our life spans and causing millions of people to live in chronic pain,” he added.
“BHITS has a treatment and research facility in Slovakia, as well as clinic facilities in China and Jamaica. Our medical and scientific teams have published research on the more than 3,000 stem cell treatments have been successfully performed in our clinics,” said Doreen Santora, chief executive officer of BHITS.
Kirk Barton, a retired NFL player, attended the screening. Mr. Barton was a member of the Miami Dolphins, San Francisco 49ers, Cincinnati Bengals, Denver Broncos and a college standout at Ohio State University, sustaining many injuries during his football career.
“It’s a demanding sport. I’ve torn my PCL, MCL, meniscus, shoulder etc. multiple times. I’ve done some research and I decided to try the stem cell therapy offered to me by Dr.Mehling at BHITS in Jamaica. It was like getting a new knee. I never felt better. I recommend it to ton of people because I believe in it,” he said.
His Excellencey Peter Kmec, Ambassador Extraordinary and Plenipotentiary, who served as the Ambassador of Slovakia to the U.S. since September 2012 attended the documentary screening and shared his insight afterwards.
“I was pleased to learn from Katarina Novakova, who spearheaded the BHITS activities in Slovakia, they’ve had more than 250 patients treated in their facility. I am proud of the company’s innovative approach and wish them success with their future endeavors in Slovakia,” said H.E. Ambassador Kmec.
“Innovation is on the top of our current agenda as well. We created a Slovak-American Business and Innovation Council (SABIC) in 2016, through which we would like to channel projects linked to startups, innovation, research, and development and to deepen trade and investment between Slovakia and US. Our goal is to help improve the Slovak innovation ecosystem through bilateral cooperation and to bring Slovakia into the family of the most competitive economies,” he added.
BHITS has conducted several clinical studies testing the safety and efficacy of human umbilical cord blood (hUCB) stem cells. Its clinical studies have provide support for the short and long-term safety of hUCB stem cells for therapy of different medical conditions, including chronic inflammation, musculoskeletal conditions, stroke and spinal cord injury. Its intent is to develop hUCB product-based therapies in Investigational New Drug Phase 1 clinical trials in order to extend lifespans and improve the quality of life for patients.
BHITS is for looking for accredited investors. The offering can be requested by emailing firstname.lastname@example.org.
June 5th, 2018 BHI Sciences