Stem Cell Clinic

‘Provocative’ Results With Stem Cells in Progressive MS – Medscape

STOCKHOLM A new trial of autologous mesenchymal stem cells in progressive multiple sclerosis (MS) has shown encouraging results, with significant benefits vs placebo in several measures of disability.

The double-blind placebo-controlled phase 2 study described as "very pioneering" and "provocative" by outside commentators was presented at the recent 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019.

Both intravenous and intrathecal administration of the stem cells showed beneficial clinical effects compared with placebo in terms of Expanded Disability Status Scale (EDSS) changes and several other functional outcomes, but the intrathecal route appeared superior to intravenous administration, reported Dimitrios Karussis, Hadassah University Hospital, Jerusalem, Israel.

Benefits were also noted mainly in the intrathecal group in relapse rates and several other secondary endpoints vs placebo, including timed 25-foot walk test, 9-hole peg test, several measures of cognitive function, and the rate of change of T2 lesion load on magnetic resonance imaging (MRI), as well as newer biomarkers including optimal coherence tomography, retinal nerve fiber layer thickness, and functional MRI motor network.

The study showed both intravenous and intrathecal administration of the cells appeared safe with no serious adverse events observed vs placebo.

"A phase 3 trial is warranted to confirm these findings," Karussis concluded.

Commenting for Medscape Medical News, Robert Fox, MD, Cleveland Clinic, co-chair of the session at which the study was presented, said the study was "provocative" as it showed "quite a robust change in disability trajectory and inflammatory markers despite only including a small number of patients."

"The data suggested a marked impact on these patients with progressive MS," Fox noted. "We've seen other stem cell trials but this is the one with the most provocative results which need to be understood further," he added.

Karussis explained that two small open-label clinical trials of mesenchymal stem cells have previously shown some indications of clinical benefits in MS and amyotrophic lateral sclerosis (ALS) patients in terms of stabilization of disability and some functional improvements.

"This third study is a double-blind, placebo-controlled trial to try and establish safety and the optimal route of administration intrathecal or intravenous injection in progressive MS," he said.

The study included 48 progressive MS patients with activity who had failed on at least one MS therapy and had an EDSS score of 3.0 to 6.5.

Mesenchymal stem cells were aspirated from the bone marrow of each patient, expanded in vivo, and then transplanted back into the patient intrathecally or intravenously at a dose of 1 million stem cells per kg body weight.

Each patient received two injections. For the first injection, 16 patients received stem cells by intrathecal injection, 16 received stem cells by intravenous injection, and 16 received placebo.

After 6 months the patients were crossed over and all patients who first got placebo were given stem cells (half by intrathecal and half by intravenous injection); those who first received stem cells were divided into two subgroups half received a second injection with the same route of administration as the first injection and the other half received placebo.

There was no major difference in baseline demographics in the three groups. Most patients had secondary progressive MS, with about 20% having primary progressive MS. The average EDSS at baseline was about 5.8 with an average progression over the previous year of around +0.7.

Efficacy results showed statistically significant benefits in patients receiving intrathecal stem cell injections vs placebo, with EDSS scores reducing by 0.2 vs an increase of 0.3 in the placebo group. The ambulation score improved by 0.8 points in the intrathecal stem cell group vs an increase of 1.3 with placebo.

The sum of functional scores improved by 3 points in the intrathecal stem cell group vs a worsening by 1 point in the placebo group. The mean number of relapses per patient were 0.06 in the intrathecal stem cell group vs 0.56 in the placebo group, and 94% of the intrathecal stem cell group was relapse free at the end of the study vs 53% of the placebo group.

There were also some smaller but significant improvements in some of the endpoints in the intravenous stem cell group vs placebo but not in the relapse rates, Karussis reported.

For the secondary endpoints patients receiving intrathecal stem cells had significant benefits in the 25-foot walk test, an improvement of 6% to 10% in walking speed vs a deterioration in the placebo group. The 9-hole peg test also showed positive results in the intrathecal stem cell group.

When comparing two treatments vs one treatment, only intrathecally treated patients showed superiority in each of the primary efficacy parameters compared with one treatment.

When asked how much of the effect was thought to be anti-inflammatory, Karussis replied that there appeared to be some dissociation between anti-inflammatory and other effects. "Gadolinium enhancing lesions were much less affected than some other disability parameters, including walking and functional MRI, which may indicate that the main effect was not immunomodulatory," he said.

Fox commented: "It will take a bit of diving into the data to understand how much might have been from an anti-inflammatory effect and how much was truly addressing the progressive facet of the disease."

"One concern was that the second 6 months of treatment patients who then went on placebo seemed to decline quite dramatically," Fox added. "So this begs the question of whether this is just a short-lived benefit and how often will these stem cells treatments need to be given."

Karussis and Fox have disclosed no relevant financial relationships.

35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019: Abstract 157. Presented September 12, 2039.

For more Medscape Neurology news, join us on Facebook and Twitter.

Read more:
'Provocative' Results With Stem Cells in Progressive MS - Medscape

‘I’ve Been Duped’: Disabled Veteran Says He Spent Thousands at Health Center With No Improvement – NBC Bay Area

Stephanie Burnette reached out to us after our first I-Team report about an expensive nerve treatment marketed to seniors. She says she and her husband still owe thousands of dollars for treatment they say didn't work for them.

While she and her husband both have neuropathy, Carlos Dominguez does not. This was confirmed by his neurologist in June and again in August.

But after his visit to Superior Health Centers in Aug. 2019, Dominguez says he didn't know what to think.

"They tell me they're going to put me through treatment to cure me," he said.

The disabled veteran says he was drawn to Superior Health Centers by an invitation offering a free dinner and the promise of stem cell treatments.

Have a tip for our NBC4 I-Team? Send it straight to their inbox.

"That's what I keep hearing is going to help people who have arthritis, which is what I have in my knee," Dominguez said of stem cells.

To his surprise, he says they also told him he had the debilitating nerve condition called neuropathy and Superior Health warned of dire consequences.

"He told me that later on you could basically have an amputation whether it be your toes or your feet ... so how are you feeling? Of course I'm scared," he said.

Dominguez said Superior Health bombarded him with paperwork he showed us the documents and pointed out more than a dozen places he had to initial and sign.

"They keep shoving one after another after another. They don't even give you a chance to stop and you know, get your thoughts straight."

When it was all said and done, Dominguez had signed up for 2 1/2 months treatment at a cost of $15,602.

The financing was arranged by Superior Health and none of the treatment costs were covered by insurance. Dominguez's neurologist confirmed after his visit with Superior that he does not have neuropathy.

And what about the promise of stem cells? Dominguez showed us a document which says Superior Health uses "human umbilical cord tissue."

"The tissuehas no stem cells or anything that could play any role in regenerating damaged organs or tissues or anything," Kevin McCormack, a spokesman for California Institute for Regenerative Medicine said.

CIRM is the state agency that funds stem cell research. McCormack warns many clinics are making big promises with no scientific proof.

"Long term it doesn't work, it doesn't repair the damage, it doesn't restore functions. It doesn't do anything. The only thing it improves is the bank account of these clinics," he said.

Chiropractor Philip Straw first came to the NBCLA I-Team's attention when viewers reached out to our investigative unit with complaints about the neuropathy treatment they received from Optimal Health/Straw Chiropractic. The I-Team started asking questions late last year. We were told in January that the business was closing its doors, but they appear to have reopened as Superior Health Centers where Carlos went.

For example, Straw is seen in television commercials advertising neuropathy treatment. When we've called the number displayed on the commercial, it connects to Superior Health Centers.

NBCLA has tried unsuccessfully to reach Straw and an attorney for Superior Health for comment.

But in a previously issued statement, the attorney wrote:

"Philip Straw is neither practicing at the facility nor is he a professional tenant of Superior Health Centers ... While patients acknowledge that there is no guaranty that they will improve from the treatment, many patients report significant improvement."

When Dominguez heard patient Michele Botts in our first I-Team report, he said her words resonated with him.

"I go, oh boy. I've been duped. That's the first thing I thought ... I've been taken," he said.

Taken for thousands of dollars and left, he says, with no improvement and no hope.

Dominguez never received any stem cell treatments. Instead, he says he told Superior Health he wanted out of his contract and cleared of his financial obligation. He says Superior has not agreed to that.

Consumers can contact the California Chiropractic Examiners Board online here or call 916-263-5355 to speak with someone.

This story is from our sister station, NBC Los Angeles. Click here for more investigative stories from NBC stations across the county.

Read the original here:
'I've Been Duped': Disabled Veteran Says He Spent Thousands at Health Center With No Improvement - NBC Bay Area

Finding alternatives to animal testing – University of California

Researchers at the University of California, Riverside, are part ofan ambitious planat the U.S. Environmental Protection Agency, or EPA, to eliminate animal testing by 2035. Their contribution: developing a way to test whether chemicals cause musculoskeletal birth defects using lab-grown human tissue, not live animals.

Nicole zur Nieden, an associate professor of molecular, cell, and systems biology, andDavid Volz, an associate professor of environmental toxicology, are both experts on alternatives to regulatory toxicity testing and chemicals policy and regulation. They received $849,811 to grow human stem cells into bone-like tissue to test industrial and environmental chemicals that might interfere with fetal growth.

Birth defects that affect musculoskeletal tissues can be caused by chemical ingredients in pesticides, fungicides, paints, and food additives. Harmful chemicals must be identified through testing in order to be regulated. Currently, this testing is done on live animals, usually rodents such as mice.

The UC Riverside project, led by zur Nieden, will stimulate human pluripotent stem cells, which have the capacity to develop into any sort of cell, with agents that direct them to form bone cells. The cells will pass through the same developmental stages and be subject to the same molecular cues as in a human embryo. The researchers will expose the cells to selected chemicals at critical junctures, then assess them using advanced imaging and next-generation sequencing techniques.

Bone cells can develop through three different pathways. zur Nieden will use chemicals known to affect specific routes of bone development to look for patterns in how the chemicals affect these origins. The patterns will serve as blueprints for testing unknown chemicals. Next, the researchers will test unknown chemicals and compare them to previously compiled libraries of compounds that have already been tested in animals to see how accurate the petri dish, or in vitro, tests are for assessing risk.

A hallmark feature of bone-forming cells is that they make a bony matrix out of little crystals called hydroxyapatite, which eventually form calcium phosphate, the white stuff on the surface of all bones. Cost-saving visual analysis can help identify defects in calcium.

Calcium crystals appear white when viewed with your eyes, said zur Nieden. But when you view the cultures using phase contrast microscopy, it inverts the light so the normal crystals appear black. Abnormal crystals will have more white and shades of gray. You can use an image analysis algorithm to measure the blackness in images to determine if the calcium has formed correctly or not.

Scientists have known for a long time that animals differ from humans in important developmental and physiological ways, and that animal test results are not always reliable for people. Moreover, animal research is expensive and time-consuming, as well as increasingly untenable for ethical reasons. Non-animal alternatives have been in development for nearly 25 years, and some are already standard.

To the general public, the EPAs announcement seemed to come out of nowhere, said Volz, whose lab will sequence messenger RNA in chemical-exposed bone cells from zur Niedens lab to look for changes in gene expression. It didnt happen overnight. That train has already left the station.

Volz said the EPAs Science to Achieve Results Program, through which UC Riverside received the new grant, has been funding research on animal alternatives for more than 10 years.

The EPAs plan to end animal testing by 2035 follows up on earlier changes to the Toxic Substances Control Act, or TSCA, enacted in 1976. TSCA authorizes the EPA to regulate chemicals found in consumer products such as cleaning agents, furniture, paint, carpeting, clothing, and other consumer goods. Regulation under TSCA does not apply to chemicals in food, drugs, cosmetics, and pesticides, which are regulated under different laws.

Even after TSCA, thousands of common chemicals used in everything from plastic to sunscreen have never been tested for safety in humans. In 2016, Congress passed the Lautenberg Chemical Safety Act, amending TSCA to close the loophole for industrial chemicals. The law mandated the EPA to evaluate existing chemicals with clear and enforceable deadlines, and to develop risk-based chemical assessments. It promoted the use of non-animal testing methods, a move sought by both industry and animal rights groups.

The new EPA plan introduces an aggressive timeline for ramping up development of non-animal tests that can accurately predict toxicity in humans. Volz said the United States lags behind some other countries around the world, which have already greatly reduced animal testing. He said he interacts with fewer and fewer students interested in research involving animal experiments, and that our culture is shifting toward a desire to reduce animal suffering.

But neither Volz nor zur Nieden are sure animal testing can ever be replaced completely, a position echoed by the EPA memo, which states that after 2035, animal tests will be approved on a case-by-case basis. Some chemicals, for example, are not directly toxic to cells but become toxic after they are metabolized in the body.

If your result is that the chemical does not interfere with a human stem cell developing in a dish, how sure can you be thats not really happening in humans? The best way we have to assess that is an animal experiment, zur Nieden said. At the same time, we want to do this in an appropriate way. We need to think about, is this really necessary? Can we look at the question some other way?

zur Nieden thinks we need a tiered system, with in vitro tests weeding out the most toxic chemicals first, and animal tests used where in vitro tests dont reveal toxicity.

If you cannot fully replace an animal test with an in vitro method, you can at least decrease suffering of the animal. If you think about a highly toxic chemical that has effects on the mom as she is exposed during pregnancy as well as on the developing embryos, if you can use an in vitro test system to find all these strong toxic chemicals, you will not need to test them in an animal, she said.

Previous versions of the test system zur Nieden will use for the new musculoskeletal research have been able to identify embryotoxic chemicals for other tissues, such as heart tissue, with almost 100 percent accuracy.

See the rest here:
Finding alternatives to animal testing - University of California

Gene therapy shows promise repairing brain tissue damaged by stroke – National Institute on Aging

From the NIH Directors Blog by Dr. Francis Collins

Its a race against time when someone suffers a stroke caused by a blockage of a blood vessel supplying the brain. Unless clot-busting treatment is given within a few hours after symptoms appear, vast numbers of the brains neurons die, often leading to paralysis or other disabilities. It would be great to have a way to replace those lost neurons. Thanks to gene therapy, some encouraging strides are now being made.

In a recent study in Molecular Therapy, researchers reported that, in their mouse and rat models of ischemic stroke, gene therapy could actually convert the brains support cells into new, fully functional neurons.1 Even better, after gaining the new neurons, the animals had improved motor and memory skills.

For the team led by Gong Chen, Penn State, University Park, the quest to replace lost neurons in the brain began about a decade ago. While searching for the right approach, Chen noticed other groups had learned to reprogram fibroblasts into stem cells and make replacement neural cells.

As innovative as this work was at the time, it was performed mostly in lab Petri dishes. Chen and his colleagues thought, why not reprogram cells already in the brain?

They turned their attention to the brains billions of supportive glial cells. Unlike neurons, glial cells divide and replicate. They also are known to survive and activate following a brain injury, remaining at the wound and ultimately forming a scar. This same process had also been observed in the brain following many types of injury, including stroke and neurodegenerative conditions such as Alzheimers disease.

To Chens NIH-supported team, it looked like glial cells might be a perfect target for gene therapies to replace lost neurons. As reported about five years ago, the researchers were on the right track.2

The Chen team showed it was possible to reprogram glial cells in the brain into functional neurons. They succeeded using a genetically engineered retrovirus that delivered a single protein called NeuroD1. Its a neural transcription factor that switches genes on and off in neural cells and helps to determine their cell fate. The newly generated neurons were also capable of integrating into brain circuits to repair damaged tissue.

There was one major hitch: the NeuroD1 retroviral vector only reprogrammed actively dividing glial cells. That suggested their strategy likely couldnt generate the large numbers of new cells needed to repair damaged brain tissue following a stroke.

Fast-forward a couple of years, and improved adeno-associated viral vectors (AAV) have emerged as a major alternative to retroviruses for gene therapy applications. This was exactly the breakthrough that the Chen team needed. The AAVs can reprogram glial cells whether they are dividing or not.

In the new study, Chens team, led by post-doc Yu-Chen Chen, put this new gene therapy system to work, and the results are quite remarkable. In a mouse model of ischemic stroke, the researchers showed the treatment could regenerate about a third of the total lost neurons by preferentially targeting reactive, scar-forming glial cells. The conversion of those reactive glial cells into neurons also protected another third of the neurons from injury.

Studies in brain slices showed that the replacement neurons were fully functional and appeared to have made the needed neural connections in the brain. Importantly, their studies also showed that the NeuroD1 gene therapy led to marked improvements in the functional recovery of the mice after a stroke.

In fact, several tests of their ability to make fine movements with their forelimbs showed about a 60% improvement within 20 to 60 days of receiving the NeuroD1 therapy. Together with study collaborator and NIH grantee Gregory Quirk, University of Puerto Rico, San Juan, they went on to show similar improvements in the ability of rats to recover from stroke-related deficits in memory.

While further study is needed, the findings in rodents offer encouraging evidence that treatments to repair the brain after a stroke or other injury may be on the horizon. In the meantime, the best strategy for limiting the number of neurons lost due to stroke is to recognize the signs and get to a well-equipped hospital or call 911 right away if you or a loved one experience them. Those signs include: sudden numbness or weakness of one side of the body; confusion; difficulty speaking, seeing, or walking; and a sudden, severe headache with unknown causes. Getting treatment for this kind of brain attack within fourhours of the onset of symptoms can make all the difference in recovery.

This research was supported in part by NIA grant AG045656.

References:

[1] Chen Y-C, et al. A NeuroD1 AAV-based gene therapy for functional brain repair after ischemic injury through in vivo astrocyte-to-neuron conversion. Molecular Therapy. 2019. Epub Sept. 6.

[2] Guo Z, et al. In vivo direct reprogramming of reactive glial cells into functional neurons after brain injury and in an Alzheimers disease model. Cell Stem Cell. 2014;14(2):188-202. doi: 10.1016/j.stem.2013.12.001.

See the original post here:
Gene therapy shows promise repairing brain tissue damaged by stroke - National Institute on Aging

Vitro Biopharma 3rd Quarter ended July 31st 2019 Financial Results of Operations – Yahoo Finance

GOLDEN, CO / ACCESSWIRE / September 26, 2019 / Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced its 3rd quarter ended September 24th 2019 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 3rd quarter in Stem Cell Revenues. Vitro Biopharma recorded 3rd quarter revenues of $225,191 vs $141,783 an increase of 59% over the same comparative quarter last year. Current quarter stem cell revenues increased 60% from the prior comparative quarter, consisting of $175,533 for the 3rd quarter ended July 31st, 2019 vs $109,717 for the third quarter ended July 31st, 2018. In the nine months ended July 31st, 2019, revenues were 78% higher than the comparable period in 2018, $629,986 in 2019 versus $354,854 in 2018.

The company's gross profit margins decreased from 76% in the comparative prior year's quarter to 66% in the current quarter. Current COGS is charged with higher cryogenic shipping costs (affecting 5% of COGS) which the company is acting to reduce by stocking inventory at its partners clinic in the Cayman Islands. Subsequent to the quarter its partner in the Cayman Islands established a cryogenic dewar storage facility to support therapies on demand and substantially reducing shipping costs. In addition the current quarter better represents the growth of all the revenue streams represented by AlloRx, InfiniVive, NutraVivo (STEMulize) and Research and Development products. Nine months ended July 31st 2019 margins held up at 71% versus 74% in the prior comparative 9 month period ended July 31st 2018.

Overall operating expenses increased in the quarter by $93,769 to $194,682 from $100,913 in the prior year's comparative quarter. The increase in expenses primarily reflects the increased costs of sales and marketing $27,919, Laboratory certifications (ISO 9001, ISO 13485, CLIA) accounting, regulatory, business development $30,048 and notes interest expenses $20,392. This represents the company's investment in its executive team and outside consultants to support the company's increased business development activities in the Cayman Islands, Bahamas and it's US and international Cosmetic partnership with Infinivive MD, operated by Jack Zamora, MD. For the 9 months ended July 31st 2019 the company grew revenues by 78% while only growing operating expenses by 16%. These investments also provide for further business development opportunities.

During the quarter the company achieved and pursed the following objectives:

The company moved forward increasing its manufacturing capacity at its current laboratory facility to support expanded operations and pre-positioning for the expanded manufacturing facilities due to go online in mid-fiscal 2020. During the quarter the company expanded its cell culture incubator capacity, cell analysis equipment and automated cryogenic equipment for expanded and automated production of its AlloRx Stem Cells and its stem cell serum product now branded as InfiniVive MD. The manufacturing equipment added in the 3rd quarter costs were $115,868 and was financed with a 5-year finance facility.

The current expansion has increased our capacity to process 15 Billion AlloRx Stem Cells a month. This represents approximately $ 4 Million of capacity per year. Furthermore, the doubling of manufacturing facility at the beginning of the 2020 year will expand our capacity to approximately 100 Billion AlloRx Stem Cells a month or approximately $1.7 Million of revenue capacity per month. This would give Vitro Biopharma a revenue run rate capacity of $20M a year. This will become our new processing capacity which will be initially 10% utilized and provide for future exponential growth.

Our increased capacity is rigorously controlled by our Quality Management System, now certified to the ISO9001 Quality Standard and the ISO13485 Medical Device Standard as well. This provides cGMP-compliant manufacturing of the highest quality stem cells/medical devices for clinical trial testing to provide further evidence of safety and efficacy for treatment for a wide variety of indications. Highly regulated cGMP biologics manufacturing within an FDA-compliant facility provides numerous opportunities to the Company to drive strong revenue growth. We are presently focused on our partnerships in the Caribbean with DVC Stem in Grand Cayman Island, InfiniVive MD in the US and emerging opportunities in the Commonwealth of the Bahamas. Recent destruction of the Bahamas due to hurricane Dorian have deferred our revenue expectations into the latter part of 2020 versus the beginning of 2020. We are actively pursuing other partnership opportunities as well; including pursuing an FDA-based IND ("Investigational New Drug") with an IRB for musculoskeletal conditions utilizing the business & manufacturing infrastructure that supported the Bahamas IRB approval. We are presently developing opportunities for diagnostic support of clinical trials of TBI and Alzheimer's disease based on our CLIA certified clinical laboratory utilizing multiplexed biomarker profiling.

Story continues

We have recently reformulated our stem cell activation product, NutraVivo, into a single capsule soft-gel format (STEMulize) that is now undergoing testing prior to commercial release. The company also entered into a memorandum of understanding with New York-based partner Magnus Ventures to develop a Nutraceutical subsidiary for Vitro Biopharma that will focus on nutraceutical therapy of stem cell activation and cellular wellness. The company and its partner are looking to launch the on-line and social media platform for STEMulize in the first half of 2020. The product is currently recommended to our partners' stem cell and cosmetic customers where it is being beta tested for enhancing and supporting cellular wellness in conjunction with the stem cell treatments. The company has scientific data supporting the natural product's capabilities of anti-inflammation, stem cell activation and other cellular effects. The structure of the new company is not finalized but Magnus Ventures is looking to raise between $500,000 to $1,000,000 for the STEMulize subsidiary to support a direct to consumer on-line marketing launch. It is anticipated that Vitro Biopharma will retain over 60% majority control of the new nutraceutical subsidiary.

STEMulize contains natural substances that activate the body's own stem cells to enhance recovery from injury such as TBI, stroke, MS, PD and other autoimmune and neurological diseases. The revised NutraVivo product will be offered as a private label product to InfiniVive clinics and is being implemented as supplemental support to clinical treatments now ongoing in the Cayman Islands. Patients report positive benefits from NutraVivo therapy following stem cell transplants including increased overall energy and improved motor function in MS patients. We are currently testing the new formulation for its commercial release and implementing a name change to STEMulize to reflect its use as a nutraceutical stem cell activator.

The Company's cosmetic stem cell serum private labelled as InfiniVive MD Stem Cell Serum is applied as a topical cosmetic beautification product that is used in conjunction with various skin resurfacing devices. InfiniVive MD continues to expand its base of authorized cosmetic partner clinics and revenues grew 98% in the quarter to approximately $105,000 vs $53,000 in the prior comparative quarter. The cosmetic surgery industry is cyclically slow in the summer months as a result the current quarter cosmetic revenues of $105,000 were lower from the previous second quarter revenues of $130,000. These developments have been in process for the last year and the Joint Development and Supply Agreement dated May 15th 2018 between Vitro Biopharma and Jack Zamora is now producing material results. The agreement requires a minimum level of performance of $1,000,000 annualized by the six-month ended period of June 30th 2020 in order to retain exclusivity in the cosmetic distribution channel.

InfiniVive MD Stem Cell Serum is revolutionizing cosmetic care. The results are delivering reduced down time and an improved beautification experience. The InfiniVive MD product offers many benefits including increased beautification, hydration and improved results compared to alternative cosmetic products. We work with a variety of regulatory consultants to assist us in the appropriate regulatory pathway. The company and its consultants considers InfiniVive MD as a cosmetic beautification product for topical use only.

http://www.jackzamoramd.com http://www.InfiniVivemd.com

Vitro Biopharma's OEM cosmetic topical serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product used in conjunction with various skin resurfacing devices. To date the company's product is being offered in 10 cosmetic clinics.

Our clinical trial entitled "Vitro Biopharma Allogeneic MSC Therapy of Musculoskeletal Conditions" was approved by the National Stem Cell Ethics Committee of the Bahama's on February 26, 2019. Subsequent to its 3rd quarter, the executive team of Vitro Biopharma visited Dr. Conville Brown and toured his facilities at the Medical Pavilion of the Bahamas. Subsequent to our trip and plans, hurricane Dorian wiped out the Islands of Abaca and Grand Bahamas but significantly spared Nassau where our partner clinic is located. However the government and hospital facilities are being taxed by devastation to property and the people. The company expects these developments to set back its revenue plans into the later half of 2020.

About the Medical Pavilion of the Bahamas: TMPB operates within a 40,000 square foot building as a partnered care specialty medical facility with 10 different centers in various areas including cardiology, cancer, clinical research and kidney disease. One of the centers is the Partners Stem Cell Centre, where the present trial will be conducted. The Partners Stem Cell Centre provides an environment to conduct stem cell research and clinical trials under the model of ''FDA rigor in a Non-FDA Jurisdiction'' TMPB employs 20 medical specialists in various fields. See http://www.tmp-bahamas.com for additional information.

While our plans in the Bahamas have been set back there is currently no revenue contribution loss, only a delay in expanding our revenue diversification.

During the quarter Vitro Biopharma continued to expand its clinical trial business in the Cayman Islands with its partner http://www.DVCStem.com under the joint IRB covering inflammatory conditions. Treatments to date have covered MS (Multiple Sclerosis), OA(Osteoarthritis), PD (Parkinson's disease) and other inflammatory conditions. DVC Stem specializes in clinical stem cell regenerative medicine utilizing Vitro Biopharma's AlloRx Stem Cells under approval of the Ministry of Health of the Cayman Islands. Subsequent to the quarter, our executive team visited DVC Stem to train personal in stem cell deployment & cryogenics based on their new onsite cryogenic storage facility.

Our overall objectives are to support high quality offshore medical stem cell tourism with clinical trial partners worldwide.

The Company has several patent applications (11) pending in the US and foreign jurisdictions. These patents cover our AlloRx Stem Cell line and various aspects of our NutraVivo stem cell activation products & processes as well as specific diagnostic tests of stem cell activity and therapeutic effectiveness. During the quarter, the Company has responded to office actions and continues to vigorously prosecute & expand its patent filings.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased to report the results of operations through our 3rd fiscal quarter in 2019. We experienced strong revenue growth over the comparative prior year quarter. Our 3rd quarter is typically a cyclical low quarter as the Research products are not in demand during the summer period as well as it is a cyclically low quarter for the cosmetic revenue stream. The company expects with continued increases from all revenue categories that it will be cash flow positive in mid. 2020 and report its first net quarterly profit in the later 2020 timeframe.

We have added several regulatory certifications and outside oversight of our biomanufacturing operations. We are now ISO9001, ISO13485 and CLIA certified and cGMP compliant. Our regulatory certifications allow us to gain offshore IRB approvals, e.g., in the Commonwealth of the Bahamas and other countries since the ISO Standards are internationally recognized. Certification to these rigorous standards are often required to perform manufacturing operations supporting IRB-approved clinical trials, especially in foreign jurisdictions.

Our stem cell products are distinctly superior to stem cell transplants in the USA. The latter usually involve use of impure products lacking validation as stem cells and containing insufficient numbers of stem cells to achieve therapeutic benefits. These are produced without regulatory oversight and have been known to cause serious adverse effects. Hence the use of highly purified and well characterized stem cells (AlloRx Stem Cells) is needed to provide safety and efficacy in regenerative medicine therapies. Results from our clinical studies show safe administration of AlloRx Stem Cells and evidence of efficacy in OA ("Osteoarthritis"), MS ("Multiple Sclerosis") and PD ("Parkinson's Disease")

Our Research and Development team is developing a novel product for clinical applications, called AlloEx Exosomes. Exosomes are secreted from stem cells and may mediate therapeutic benefits without the use of stem cells. The mechanism of stem cell effects on the body is complex, but exosomes offer an important line extension to AlloRx that represents further revenue diversification opportunities for Vitro Biopharma.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10+ years experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapies. We continue to leverage our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide."

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro Biopharma(303) 999-2130 Ext. 1E-mail: jim@vitrobiopharma.com

SOURCE: Vitro Diagnostics, Inc.www.vitrobiopharma.com

Vitro Diagnostics, Inc.3rd Quarter ended July 31st;Income Statement

Stem Cell Therapies and Treatments

Stem Cell Products

Other Services

Total Revenues

COGS

Gross Profit

SGA Expenses

Office Expenses

Consulting,Accounting,Legal and Banking Fees

Laboratory R&D & Quality Control

Total Operating Expenses

Net Operating Profit (Loss)

Non Cash Depreciation and Amortization

Non Cash Stock for Services

Non Cash Interest on Secured Notes Payable

Non Cash Interest on Shareholder Debt

Net Income (Loss)

Vitro Diagnositics Inc.3rd Quarter Ended July 31st;Balance Sheet

ASSETS

Cash

Accounts Receivable

Inventory

Notes Receivable and Prepaids

Current Assets

Fixed Assets

Intangible and other Assets

Total Assets

LIABILITIES

Trade Accounts Payable

Bank Credit Cards

Capital Lease Obligaitons

Current Liabilities

Secured Convertible Notes

Capital Lease Obligations

Shareholder Accrued Comp. Payable

Shareholder Debts Payable

Long Term Liabilities

Total Liabilities

SHAREHOLDERS EQUITY

Common Stock

Paid in Capital

Retained Earnings

Net Income

Total Equity

TOTAL LIABILITIES AND EQUITY

Vitro Diagnostics, Inc.QIII ended July 31st; Statement of Cashflows

Net Loss QIII ended July 31st;

Non Cash Depreciation and Amortization

Decrease in current and other Assets

Increase in Current and other current Liabilities

Net cash used in operations Quarter ended July 31st 2019

Cashflows from Investing Activities during the Quarter

Equipment and Patent Expenditures

Equipmment Financing

Increase in Notes Payable

Non Cash Secured Note Interest

Non Cash Shareholder Note Interest

Net Cash provided by Financing Activities during the Quarter

Net Increase (Decrease) in Cash Quarter ended July 31st 2019

Cash Beginning of the Quarter May 1st 2019

Cash Quarter ended July 31st 2019

Vitro Diagnostics Inc.3rd Quarter ended July 31st 2019Statement of Changes in Shareholders Equity

Balance April 30th 2019

Balance July 31st 2019

The fully diluted Shares outstanding consists of;

Currently issued shares

Excerpt from:
Vitro Biopharma 3rd Quarter ended July 31st 2019 Financial Results of Operations - Yahoo Finance

Science Talk – Celebrating Professor Sir Mel Greaves and his legacy in leukaemia research – The Institute of Cancer Research

I joined a group of leading figures from around the world in leukaemia research recently as they gathered at the Royal Society to celebrate Professor Sir Mel Greavesoutstanding contributions to the field, and his recent knighthood.

Throughout the day, speakers gave talks on some of the giants of leukaemia research Sidney Farber, John Goldmanand Donald Metcalfto name a few.

Each scientist who spoke emphasised Sir Mels impact on the field and told touching personal stories about how he inspired their own scientific careers.

Professor Mel Greaves was knighted in 2018, for his groundbreaking work to understand the hidden natural historyand causes of childhood leukaemia during a 35-year career at The Institute of Cancer Research, London.

Find out more

Dr Elli Papaemmanuil, who is currently at The Memorial Sloan Kettering Cancer Centerin New York, spoke about how fortunate she felt to have crossed paths with Professor Greaves during her time at the ICR. I would not be a scientist if it were not for Mel, she said, with clear enthusiasm for both Mels mentorship and the scientific findings she presented.

Dr Papaemmanuil recalled that on a recent visit to her lab, Mel spent an hour with each of the scientists she supervises, taking the time to work through problems with them and sharing his expertise generously.

Describing her work, she explained the causes of leukaemia, with complex interplay between genetic mutations and chromosomal translocations a change in which large chunks of two chromosomes get swapped over which can cause disease.

She recounted how she emailed Mel one Christmas, excited by her findings and asking for some input, and he politely told her that as it was the holiday season, she should go home and be with her family. This commitment to balancing a scientific career with family was echoed throughout the day, with Mel hailed as a mentor who encouraged a good work-life balance in combination to a devotion to his work.

She finished up by thanking Mel for the phenomenal impact he has had in the field and on individual scientists, and it was clear from the rapturous applause in the room that her words struck a chord with many in attendance.

Running through all of the talks was a thread of scientific dedication from these researchers the word obsession was used by numerous speakers to describe the fervent nature of the devotion these scientists give to the cause of leukaemia.

Why do children get leukaemia? Why does one child of a set of identical twins develop the disease while the other twin an exact genetic copy escape unscathed?

Delving into these questions is what led these international researchers to the top, and their achievements over the last 60 years have been truly remarkable.

Acute lymphocytic leukaemia (ALL) was once 100 per cent lethal, and now has a 90 per cent cure rate. More is understood about the genetics of leukaemia than ever before, and many of the scientists spoke about standing on the shoulders of giants.

Our research into childhood leukaemia has had an enormous impact on the lives of children with cancer all across the world. With your support today, we can make ALL a disease of the past.

Support our appeal

John E Dick, who is based at the Princess Margaret Cancer Centrein Toronto, spoke of a sabbatical he took in Mels lab early on his career, and how working there set him off down a path of scientific questions he had not previously considered.

Thinking about the nature of stem cells he wondered why the fate of some of these cells is to become endlessly proliferating cancer cells, and why some remain healthy.

This led him to discover that while some people have genetic changes which are precursors to leukaemia, they dont go on to develop the disease more changes are necessary to kick off the reactions that cause leukaemia.

He concluded with the strong statement that we cannot divorce stem cell biology from evolution, and thats a legacy Mel has given us all.

Mel began his own talk at the end of the day with a reference to Charles Darwin, who he argued came up with the best idea in science, ever with his theory of evolution by natural selection. Mels enthusiasm for science was palpable by all in the room and is positively infectious.

His lecture, entitled the Li Chong Chan lecture, was named in honour of a former researcher who worked with Mel. Li Chong Chan was a Clinical Fellow and PhD student in Mels laboratory at the ICR (198487).

Mel praised the young PhD students, post-docs, and junior scientists who he emphasised are of equal importance as the prestigious scientists who might have come before them.

He emphasised a point made by many researchers throughout the day: little advancement in science comes from a truly original eureka moment of totally original thought. We are always building on the work of the scientists who came before is.

Professor Greaves then led the audience through some of the highlights of his career, touching on the importance of identical twins in his research and explaining that many cancers arise as a result of a mismatch between modern lifestyles and the way human beings have evolved.

The body has been crafted by the process of evolution to withstand all sorts of stresses, but the modern world presents a unique set of challenges, many of which let cancerous cells flourish and develop into disease.

Throughout September, The Institute of Cancer Research is recognising Childhood Cancer Awareness Month with news stories, videos and blog posts that highlight our latest efforts to improve the lives of children with cancer.

Find out more

One of the most promising avenues of research Professor Greaves feels will make an impact on cancer prevention in future is a set of treatments targeting the microbiome the mix of good bacteria which live in and on the human body, mostly in the gut.

The development of a healthy gut microbiome starts early in life. This microbiome helps protect us against infections, aid in proper digestion, and also helps to prime the immune system, which in turn affects the likelihood of developing leukaemia.

Professor Greaves'excitement about this avenue of research is clear, and hes showing no signs of slowing down his research. Recognising that his ideas are audacious, he said Im an optimist. Unless you couple being audacious with being an optimist, theres no point.

After Mels lecture, the day finished up with some closing remarks from the ICRs Chief Executive Professor Paul Workman, who thanked everyone for attending and summed up the day by saying of Mel, Not only is he a great scientist, hes just a great human being.

Read more:
Science Talk - Celebrating Professor Sir Mel Greaves and his legacy in leukaemia research - The Institute of Cancer Research