Miracle of Regeneration in Placentas, a New Focus for Investment: Interview with Dr. Harrell, CEO of Regenerative Processing Plant, LLC
几周前的除夕时，Celularity，一家开发胎盘干细胞的公司获得了2500万美元的投资，干细胞治疗再次成为了投资热点。然而在上一次干细胞投资热潮中，人们发现这种神奇的细胞并不好驾驭。然而自2013年起，兰德尔·哈勒尔（Randall Harrell）博士和他的 Regenerative Processing Plant（下文简称PRR）公司采用了一种新的干细胞开发思路，成功将6款产品推向市场，即将完成同样是千万美元级别的B轮融资。
A few weeks ago, on Chinese New Year’s Eve, Celularity, a company which aims to develop placental products, has received a $250 million investment. Stem cell therapy has once again become a hot spot for investment. However, in the last boom of stem cell investment, people discovered that stem cells are not easy to manage. But since 2013, Dr. Randall Harrell and his company, Regenerative Processing Plant, LLC, have adopted a new idea for the development of stem cells and successfully introduced 6 products to the market. They have their A-Round financing and are now looking for B-Round financing.
Dr. Randall Harrell
Plastic Surgery: A Serious Basic Science
哈勒尔博士是一位资深的整形医生，他毕业于德州贝勒医学院，曾在埃默里大学从事肿瘤免疫学研究，之后师从心血管手术之父Michael Debakey 研究再生医学——那时候甚至没有再生医学这个概念，至今已经四十年了。人们可能会好奇，为什么一个整形医生会对再生医学感兴趣？在大众的印象中，似乎整形医学就是整容术，就是制造“网红脸”。“很多人不知道，”哈勒尔博士说，“第一例移植手术就是由整形医生Joseph Murray完成的。他是移植手术之父，在1954年他成功实现了首次肾移植，因此荣获诺贝尔奖。”
Dr. Harrell is a seasoned plastic surgeon. He graduated from Baylor College of Medicine in Texas and studied tumor immunology at Emory University. He then studied with Dr. Michael Debakey, the father of cardiovascular surgery to work on regenerative medicine, when the concept of regenerative medicine had not been raised. He has been in this career for forty years. People may wonder why a plastic surgeon would be interested in regenerative medicine. In the public’s impression, it seems that plastic surgery is a cosmetic surgery intended to create a more aesthetically beautiful face.
“A lot of people don’t know,” said Dr. Harrell, “that the first organ transplant was done by a plastic surgeon, Dr. Joseph Murray. He was the father of transplant surgery. In 1954 he succeeded in achieving the first kidney transplant and was rewarded the Nobel Prize in 1990.”
The original purpose of plastic surgery was to reshape the facial features for the wounded soldiers after the war. In order to repair the injured organ, two ideas have emerged: One is to use donated organs to repair the injury, which has led to today’s transplantation. Yet another more revolutionary idea is to stimulate people’s ability to repair themselves. If people can repair their injuries like lizards or newt, why should they look for organs desperately all around the world? This idea is the foundation of the emerging regenerative medicine, which is Dr. Harrell’s pursuit.
“We can regenerate the body instead of doing surgery.”
Dr. Harrell believes that “In the future it would be a lot easier to inject medicine instead of doing surgery. We are going to inject things to stimulate people’s stem cells.”
1989年，哈勒尔博士在佛罗里达州成立了自己的整形诊所“青春之泉”，一边进行传统整形手术（迄今一共服务超过5万位患者），一边开发产品。2013时，哈勒尔博士发现“我已经有了太多的专利，”于是决定成立Regenerative Processing Plant，“为了人类的福祉，发展这些专利。”目前与RPP公司直接相关的专利共18项，哈勒尔还有更多的专利择机而用。
In 1989, Dr. Harrell established his own “Fountain of Youth” clinic in the state of Florida, where he performed traditional plastic surgery (having served 50,000 patients so far) while developing regenerative medicine products. In 2013, Dr. Harrell found that “I’ve got many patents”. So he decided to establish the Regenerative Processing Plant, LLC, and began to develop patents and products for the welfare of human being. Currently, there are 18 patents related with Regenerative Processing Plant while he has more patent for reserve.
此外，哈勒尔博士2001年时还曾参加过Medical Mission International组织的对中美洲国家萨尔瓦多的医疗救助，这项壮举曾获得诺贝尔和平奖的提名。
Of all those patents, which one is the proudest one for Dr. Harrell? He said, “The most valuable one is the patent which we just got issued in February this year. It gives us a strong patent position and will be the basis for the development of other patents.” Dr. Harrell runs his own clinic, while continuing to develop patents, and now he needs to run the company. But he said, “If you have a passion, you don’t think it is work.’”Dr. Harrell sometimes gets up at 4 AM and works 80 hours a week. His passion for orthopedics and regenerative science inspire him to make continual breakthroughs.
In addition, Dr. Harrell also participated in the medical assistance organized by Medical Mission International to El Salvador in 2001. This feat was nominated for the Nobel Peace Prize.
Dr. Harrell with KY Gov. Matt Bevin, reported by CBS
Placenta Based Biomaterials
Regenerative Processing Plant, LLC has been founded for 5 years. They have 6 products on market now, which are proteins and cytokines bioengineered from placentas. Their placentas are donated by a third party non-profit organization and the supply is sufficient.
There are many valuable stem cells in the placenta. Therefore some mothers will save them as a medical gift for next generation. Dr. Harrell would describe those placentas as “gold mine”. The “gold” mined by Regenerative Processing Plant, LLC has 770 cytokines, chemokines and growth factors instead of one single protein. Researcher who have done cell culture will know that a little ‘serum’ of unknown composition is always necessary for the medium, and those serum can’t be synthesized artificially yet. Scientists have also discovered some important molecules, such as the GDF11, known as “Youth Molecule”, which has drawn a lot of attention recently.
哈勒尔博士开发的药物比较接近丙种球蛋白这些血液制品，在FDA有特殊的管理办法。FDA将人体细胞、组织及其相关产物（HCT/P）分为多个种类，如脐带血这样直接来源于人体、主要用于移植的组织和细胞纳入联邦管理法规中第12章以及公共卫生法案第361节的管理（21 CFR 1271, PHS 361），只要证明产品的安全性（不含传染病）即可，不需要进行漫长而昂贵的临床试验。而更广为人知的克隆细胞、免疫细胞、基因疗法等特殊细胞属于PHS 351管理，需要进行临床试验才能向FDA申请上市许可。
Inside of chemical compounds or engineered proteins, Dr. Harrell’s products are closer to blood products such as gamma globulin. FDA classifies human cells, tissues, and cellular and tissue-based products (HCT/P’s) into multiple categories. Products such as umbilical cord blood (which is derived from human body directly, containing tissues and cells that are used primarily for transplantation) are subject to the regulatory of part 1271 of Code of Federal Regulations Title 21 and the Section 361 of Public Health Act, which only require proofs of safety(without infectious diseases) instead of long and expensive clinical trials.Some widely known special cell products such as clone cell, CAR-T cell, and gene therapy are subject to the regulatory of Section 351 of PHS, which requires clinic trails before a company can apply for marketing approval from the FDA.
(“Regulations for the Administration and Registration of Medicines” in China stipulates that blood products fall in Category 5 can be waived for safety data after submitting relevant materials or certificates if the dose of the product do not exceed the physiologically tolerated range and if the product has not been treated by special processes including special solvents.)
8 Products of Regenerative Processing Plant, LLC (6 are available in US)
These human-derived cell growth factors are generally not immunogenic and do not cause an immune response. Therefore although there are over 70,000 treatments that have been administered, there are no side effects which need to be reported to FDA. These proteins are like serum in cell culture medium, which has a magical effect of promoting tissue regeneration.
Among patients who have used the company’s products was a woman who benefited from atomization therapy to avoid a lung transplant which would have cost $200,000. She was barely able to walk, but now is walking with no shortness of breath. There was an overweight patient who would needed a $50,000 knee transplant. However, after using Dr. Harrell’s injectable product, he grew new cartilage and now is able to exercise. Many patients are using the eyedrops alone to avoid periocular grafts. Although these are all excellent cases, Dr. Harrell also understands the importance of solid scientific evidence. Regenerative Processing Plant will start clinical trials as soon as possible after the B-round of financing.
Dr. Harrell with recovered patient who benefit from PurAgen®
The products of Regenerative Processing Plant, LLC are derived from placentas while the core technology comes from the “D-MAPPS” cell signal transduction technology platform developed by Dr. Harrell, a comprehensive pathology model platform. This platform is also the key difference between Regenerative Processing Plant and traditional stem cell companies. Dr. Harrell believes:
“We work on how cells communicate with each other……We can bypass a lot of problems people has with stem cell (like immune response or infection) and stimulate your own stem cells to get the effect we want not by using somebody else’s stem.”
In addition, Dr. Harrell’s unique sterilization method is also one of the highlights of the company. If biomaterials are sterilized by high temperature, the active ingredients would be lost or die. Dr. Harrell has developed a cryo-sterilization method to avoid damage caused by traditional sterilization like high temperature, chemical reagents or radiation sterilization. Interestingly, this sterilization method is largely protected by trade secrets and it is a FDA-certified trade secret.
Regenerative Processing Plant, LLC has a steady flow of money already
Unlike many money-burning biotech start-ups, Dr. Harrell’s company has been established for 5 years. 6 products have been prescribed by 500 doctors for 70,000 treatments, which produce a steady income. Although Regenerative Processing Plant is a private company and is not required for public disclosure, Dr. Harrell has demonstrated the company’s revenue prospect with Regener-Eyes®, an eye drops for dry eye syndrome.
Dry eye is a syndrome of ocular surface damage caused by abnormal tear quality, affecting 30 million people in the United States alone. Dry eye is difficult to cure and generally requires long-term drug control. In China, artificial tears are the mainstay while the sales of cyclosporine eye drops (Restasis®), manufactured by Allergan, has reached $1.5 billion last year.
Regener-Eyes® has a very good palliative effect on dry eyes, and even some patients who are resistant to Restasis® respond favorably to Regener-Eyes®. A bottle of Regener-Eyes® is available to patients at a price of $156-195 per bottle and could be used for a month. The same does of Restasis® costs nearly $400 per bottle. Since dry eyes require long-term drug control, patients will become long-term customers once they find it is effective. Regenerative Processing Plant, LLC has partnered with Vision Source, the largest supplier of eye care products in the United States, and is training doctors to promote Regener-Eyes® on a large scale.
Patient who recovered thanks to Regener-Eyes®. Hear her testimonials at http://mydryeyes.org/testimonials.html
Products of Regenerative Processing Plant have not been covered by Medicare yet, but the company has credit options for patients who are temporarily unable to pay. At present, it is difficult to get the US Medicare system to agree to cover new procedures, medications or biopharmaceuticals. However, Medicare approval is Dr. Harrell’s future goal.
In addition to targeting general consumers, Regenerative Processing Plant has also signed Distribution and Pricing Agreement with the US Department of Defense to provide four special products. It can be said that using Regenerative Processing Plant’s products is supporting the treatment for American soldiers.
Regenerative Processing Plant, LLC is looking to complete Round B financing of USD $10 Million and has prepared to declare new products in China.
The financing of Regenerative Processing Plant, LLC has reached the B Round. Dr. Harrell plans to complete a financing of $5 million to $10 million by April. This funding will be used to expand production capacity. Currently a partner who “is larger than Apple” has expressed interest in investing $5 million.
Dr. Harrell still welcomes more investment, and especially hopes to cooperate with Chinese investors. There are many Chinese professors on the Regenerative Processing Plant’s Advisory Committee. Dr. Harrell himself has an excellent relationship with China and Chinese physicians. One of Dr. Harrell’s former partners was Dr. Lu. Together they tested a wrinkle-removing product in 5 hospitals in Beijing and eventually obtained preliminary approval from the CFDA. Unfortunately, Dr. Lu passed away and the project was forced to be interrupted. Dr. Harrell is currently preparing to reapply and complete the long-cherished wish of his old friend.
In addition to Regenerative Processing Plant, LLC products, Dr. Harrell also has many patents that can be developed as traditional R&D route. With the successful financing of Celularity, Dr. Harrell believes that more and more people will begin to pay attention to placental products.
Finally, Dr. Harrell said “A lot of people know about stem cells and regenerative medicine…… There are a lot of things we have patented and we could do without stem cells. We work on stem-cell stimulators and we will affect a lot chronic diseases by stimulating people’s own stem cells. We have the right strategic partners and we could do lot of things and we could be bigger than Apple in the future!”
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