Stem cell pioneer sets sights on Japan – Japan Times features Neil Riordan, PhD of Medistem Panama

Japan Times Article Medistem

“We enjoy the advantage of having a large amount of clinical data on 2,000 patients. So we analyzed who received which cells and which cells worked best in different conditions. This allowed us to create our selection process through molecular profiling,” explained Medistem (Panama) Founder and CEO Dr. Neil Riordan.

Operating what is arguably the country’s most advanced laboratory, an 8,000-sq-ft facility in the City of Knowledge science and technology cluster, Medistem has raised its profile in recent years as it develops stem cell-based products for clinical trials for treatment of autism, asthma, multiple sclerosis, osteoarthritis, rheumatoid arthritis and spinal cord injuries.

Utilizing its patented technologies, Medistem harvests human adult stem cells from umbilical cords, tissues and blood as well as from bone marrow and adipose tissue. “We have intellectual property on a methodology for basically defining which are good cells, which are mediocre and which are the useless ones. The U.S. Food and Drug Administration has approved our cells for compassionate use in the United States. This is a big step,” Riordan said.

Compassionate use, also known as expanded access, refers to the use of investigational new drugs outside of a clinical trial by patients with serious, life-threatening conditions. After finishing its first prospective clinical trial, and with six others in the pipeline, the company is considering the favorable regulatory conditions for cell therapy in Japan, now a promising market for its products.

“Japan has a law on the books that allows a company of our size to commercialize such products. That makes it our number one priority. We are gearing up to present our data to regulators, as well holding talks with potential partners over there,” Riordan added.

Allogeneic and autogolous stem cell therapy combined with physical rehabilitation: A case report on a chronically injured man with quadriplegia

Allogeneic and autogolous stem cell therapy combined with physical rehabilitation - A case report on a chronically injured man with quadriplegia

Daniel Leonard in Panama

This is a research paper written by Rebecca Johnston, Daniel Leonard’s sister. She recently graduated from a Physical Therapy degree program, and wrote her Capstone paper about Daniel’s stem cell therapy treatment in Panama.

Daniel is presented anonymously in the paper, but Rebecca and Daniel have given their permission for this paper to be shared. Daniel’s ASIA scores (pre and post treatment) are in the appendix of this paper.

 

Allogeneic and autogolous stem cell therapy combined with physical rehabilitation: A case report on a chronically injured man with quadriplegia

Abstract:

Background and Purpose: Stem cell therapy for SCI is a potentially promising treatment with increasing interest. This case report describes the use of a particular stem cell therapy protocol for a patient with chronic spinal cord injury, and describes his subsequent therapy and outcomes.

Case Description: The patient is a 29-year-old male who is chronically injured from a cervical spinal injury, resulting in quadriplegia. The patient was treated with a combined protocol of intrathecal (IT) and intravaneous (IV) allogeneic MSC and CD34+ cells and IT autologous BMMC at 6 ½ years post-injury. The results track the patient’s physical therapy progress until 6 months following stem cell treatment.

Outcomes: Recovery of strength in upper extremity and lower extremity muscle groups was noted, along with a functional increase in grip strength, ability to ambulate with assistance, and a significant decrease in daily medications.
Discussion: This case supports further investigation into treatment of chronically injured SCI patients with stem cell therapy followed by physical therapy.

Manuscript word count: 4321

A few highlights:

“After the patient underwent the stem cell treatment and returned to outpatient physical therapy in his hometown clinic in the United States, his MMT scores were tested over the period of 5 months post-stem cell treatment…. The patient did not decrease in strength in any of the muscles tested, and experienced improvements in 6/13 upper extremity muscle groups, and 8/9 lower extremity muscle groups.”

“The patient also had an increase in grip strength. His grip strength was measured by his occupational therapist to be 5 lbs on the right and 25 lbs on the left at one month before his stem cell treatment. Six months later, his grip strength was measured to be 22 lbs on the right and 36 lbs on the left. The patient reported that this increase in grip strength led to functional improvements, such as being able to self-catheterize, which he was completely unable to do since his injury.”

“The patient was also able to ambulate for the first time in 5 years at approximately 4 months after finishing his treatment. He was able to ambulate in partial weight bearing with the harness and max assist of two for 40 yards at .5 MPH.”


The original post on Daniel Leonard’s blog can be found here.

Umbilical cord stem cells may lead to new spinal cord injury and multiple sclerosis treatments

Researchers in Florida have accomplished converting umbilical cord stem cells into other cell types. According to University of Central Florida bioengineer James Hickman, it’s the first time that non-embryonic cells have accomplished this feat. His research group published this work in the January 18th issue of ACS Chemical Neuroscience.

Two major benefits of umbilical cord-derived stem cells are that they have not been shown to cause adverse immune system reactions and they pose no ethical issues since they come from a source that would be naturally discarded anyway.

Hedvika Davis, a post-doc researcher and lead author of the paper, had to search for the right chemical to coax the stem cells into becoming oligodendrocytes, which are cells that insulate nerves residing in the brain and spinal cord.

Other researchers had already shown that oligodendrocytes bind with a hormone called norepinephrine and Davis theorized that this could be the key. So she used norepinephrine and other growth factors to induce the cells to differentiate into oligodendrocytes. The only problem was that the cells were not sufficiently developed as they would be in the body.

So Davis devised a novel approach of approximating the body’s environment in the lab. By growing the cells on top of a slide, with another slide on top, Davis was able to simulate a 3-dimensional environment and grow mature oligodendrocytes.

Because oligodendrocytes produce myelin, researcher believe that this discovery might lead to treatments for multiple sclerosis, spinal cord injury and diabetic neuropathy.

AuxoCell Laboratories Licenses Umbilical Cord Tissue Stem Cell Service to PerkinElmer’s ViaCord

Viacord Press Release
Cord blood private banking involves storing your own cord blood mononuclear cells in case you need them later. Cord blood public banking involves banking the cells into a public pool so that if others need them, they have access to them. In some ways it seems like cord blood private banking is based more on hope than on reality. The majority of uses of cord blood are in leukemias. In patients with leukemia you need to use the cord blood of a related or unrelated donor, but rarely if ever do you want to use your own cord blood because it may have the leukemic mutations in it that caused the leukemia to appear in the first place. Therefore, the majority of cord blood banking is based on the belief that in the future the FDA will allow for procedures to take your banked cord blood, manipulate it to generate certain tissues in vitro and then reimplant those tissues back in you if you need them. There are of course exceptions to this. For example, there are clinical trials using your own cord blood for the treatment of cerebral palsy. Specifically, Georgia Health Sciences University is doing a 40 patient cord blood study in patients with cerebral palsy who have stored their own cord blood http://www.clinicaltrials.gov/ct2/show/NCT01072370. Additionally, Joanne Kurtzberg from Duke is performing an 120 patient study in children with cerebral palsy that have stored their own cord blood http://www.clinicaltrials.gov/ct2/show/NCT01147653. Other diseases are also being explored experimentally. Clinical trials are also being performed using patient’s own cord blood for type 1 diabetes. A group in Germany is doing a 10 patient trial http://www.clinicaltrials.gov/ct2/show/NCT00989547 and a group in Florida recently completed a 23 patient trial http://www.clinicaltrials.gov/ct2/show/NCT00305344.
Thus at present the field of private cord blood banking may have some very high future potential. Large companies are realizing this and accordingly are moving into this space. Perkin Elmers announced today that it has licensed technologies patented by AuxoCell Laboratories involving processing and storage of mesenchymal stem cells from the umbilical cord. As we discussed previously on the Cellmedicine website, the umbilical cord possesses mesenchymal stem cells that are in some ways more potent than bone marrow mesenchymal stem cells because they are more immature. The licensing of this technology will allow for Perkin Elmers to deliver to customers the ability to bank not only hematopoietic stem cells but also mesenchymal stem cells. There are many uses for mesenchymal stem cells. In fact numerous clinical trials have been performed using autologous mesenchymal stem cells for conditions ranging from heart failure, to graft versus host, to spinal cord injury.
“AuxoCell is pleased to partner with PerkinElmer’s ViaCord in offering umbilical cord tissue banking and expand our strategic partnerships to bring novel stem cell therapies from the bench to the bedside,” said Kyle Cetrulo, chief operating officer of AuxoCell Laboratories, Inc. “Partnering with ViaCord was an easy decision. They are the first family bank in the United States to freeze treatment-ready cord tissue stem cells upon arrival at the lab, which enables them to be ready for immediate use, if needed.”
“ViaCord is excited to offer another source of stem cells to our customers and believe we have found an excellent partner in AuxoCell. The agreement grants ViaCord’s customers exclusive access, in family banking, to expanding MSCs derived from cord tissue through AuxoCell’s elite patents,” said Morey Kraus, ViaCord’s chief scientific officer. “AuxoCell’s proprietary and validated manufacturing protocols will assist ViaCord in offering the very best in stem cell banking.”

2011-03-31T20:04:02+00:00 March 31st, 2011|Cord Blood Stem Cells, News, Stem Cell Research|

Beike Biotechnology Reports on 114 Patients Treated with Novel Cord Blood Stem Cell Protocol

New Approach Opens Door to Expanded Uses of Cord Blood Stem Cells
Beike Biotechnology Press Release

Beiki Biotechnology and Medistem Inc (MEDS.PK) report positive safety data in 114 patients with neurological conditions treated using Beiki’s proprietary cord blood stem cell transplantation protocol. In the peer-reviewed paper “Safety evaluation of allogeneic umbilical cord blood mononuclear cell therapy for degenerative conditions” available at http://www.translational-medicine.com/content/pdf/1479-5876-8-75.pdf ., a team of researchers from Bieke Biotechnology, Medistem Inc, University of Western Ontario, Canada, and University of California, San Diego, describe biochemical, hematological, immunological, and general safety profile of patients with neurological diseases who were observed between 1 month to 4 years after treatment. No serious treatment associated adverse effects were observed. The current report aims to serve as an “expanded Phase I” study, with efficacy data to be published in a subsequent paper.

“Although it is well understood in the scientific community that cord blood stem cells are useful in treatment of terrible degenerative diseases ranging from heart failure, to stroke, to ALS, to multiple sclerosis, the fact that under current protocols immune suppressants are necessary, limits the use of cord blood to treatment of leukemias in the United States and Western Europe.” Said Dr. Hu CEO of Beike . He continued “This is the first time someone has demonstrated on such a large patient population feasibility of non-matched, non-immune suppressed, cord blood stem cell transplantation.”

The current medical dogma states that patients receiving cord blood transplants need to be immune suppressed, otherwise the cord blood will cause a devastating condition termed graft versus host. Due to the potentially lethal effects of immune suppression, cord blood stem cells are not used on a widespread basis, with the exception of treating aggressive leukemias. The technology developed by Beike allows the use of cord blood stem cells without immune suppression, thus opening up the use of this procedure to a much wider patient population.

“It is our honor to collaborate with Beike on this seminal publication. We at Medistem have been developing the concept of “universal donor endometrial regenerative cells”, which are a new stem cell that does not require tissue matching. The fact that Beike has been able to demonstrate safety of transplant by manipulating an established stem cell source is a substantial advancement for the field.” Said Thomas Ichim, CEO of Medistem Inc. “Concretely speaking, the findings of the current paper could open up the use of cord blood for non-hematological diseases, something that to date has not been performed on a wide-spread basis.”

2010-09-02T15:48:33+00:00 September 2nd, 2010|Cord Blood Stem Cells, News, Stem Cell Research|

Histostem Works With Korean Government Agency to Provide Cord Blood Storage for Multicultural Families

The US company Amstem through subsidiary signed a
partnership agreement with the Songpa-Gu Office of the Seoul Metropolitan
Government, to provide umbilical cord blood banking to multicultural families
for up to 15 years.  Cord blood is currently used for treatment of patients with
blood disorders such as leukemias as an alternative to bone marrow. 
Unfortunately many patients do not have suitable donors, this is especially true
in patients of various ethnicities.  The current program is designed to overcome
this problem.

The president of AmStem International, Inc., David Stark
 stated  "This provides AmStem and Histostem with another ‘badge of validity’
with government health agencies around the world. A diverse genetic catalogue of
autologous, HLA-typed stem cell resources such as cord blood is in extremely
high demand right now — not only by individual families, but by
government-sponsored scientists and other researchers worldwide. This is exactly
the kind of collaborative, networking opportunity that AmStem hopes to expand in
North America and Europe."

In recent years the use of cord blood for diseases not
associated with blood has been increasing.  For example, the Cord Blood Bank
Viacell has patents on the use of cord blood for treatment of Duchenne Muscular
Dystrophy (Kraus et al. US patent #7452529 – Treatment of muscular dystrophy
with cord blood cells
).  The Cellmedicine.com group has collaborated with
the US company Medistem at publishing use of cord blood together with other
cells for treatment of a patient with Duchenne Muscular Dystrophy that resulted
in functional improvement (Ichim et al. Mesenchymal stem cells as anti-inflammatories:
implications for treatment of Duchenne muscular dystrophy. Cell Immunol.
2010;260(2):75-82
).  The reason why cord blood appears to be useful in
treatment of a variety of conditions is believed to be due, at least in part, to
ability of the cells to produce numerous therapeutic factors that stimulate stem
cells already in the body to start multiplying.  Additionally, numerous studies
have shown that cord blood derived stem cells can produce cells ranging from
liver to brain to heart muscle.  A description of cord blood stem cells may be
seen on this video

http://www.youtube.com/watch?v=z6CP-OL1Kuc
.

Dr. Hoon Han, AmStem’s Chairman, commented on the cord
blood bank, "With more than 1.1 million foreigners now living in Korea, the
number of multicultural marriages and families is on the rise. By providing
these families the opportunity to store the donated umbilical cord blood, we
give them access to autologous stem cells that may be used in the future
treatment of certain cancers, such as leukemia, as well as immune and genetic
disorders. In addition, by addressing the multicultural population in Korea,
this collaborative opportunity also increases the genetic diversity of the
available supply of umbilical cord blood derived stem cells — which may benefit
Korean and foreign patients alike.
"

Cord blood stem cells help meet minority marrow needs

Leukemias are cancers of the cells that give rise to white
blood cells.  For example in myeloid leukemias the cells that normally would
become the blood cells neutrophils or macrophages start to make copies of
themselves but refuse to mature.  What happens is that the body is flooding with
cells that on the one hand do not protect the patient from disease, and on the
other hand start to interfere with organ function.  In lymphocytic leukemias the
cells that give rise to lymphocytes such as T and B cells, stop maturing. 
Despite advances in our knowledge of the molecular basis for many leukemias, in
many situations the only definitive cure can be achieved through stem cell
transplantation. Traditionally this has been performed using bone marrow stem
cells from donors that are matched with recipients.  The process of
transplantation involves initial destruction of the recipient bone marrow and
leukemic cells by administration of high doses of radiation and chemotherapy. 
Subsequently donor bone marrow is given which contains high numbers of stem
cells.  These donor stem cells eventually take over the function of making blood
and the recipient is cured of leukemia but has someone else’s stem cells inside
of them.

One of the major barriers to complete success of bone
marrow transplantation is that donors must be matched very strictly.  If the
donor is not matched then the immune cells in the bone marrow start to attack
the recipient.  This is called graft versus host disease, and is one of the most
devastating side effects of bone marrow transplantation, which in some cases is
lethal.

The current story from CNN describes a personal experience
of a lady, Diana Tirpak, who could not find a bone marrow donor.  In general it
is rather difficult to find an unrelated matching donor.  In minorities the
process is even more difficult.  Tirpak, a retired school nurse in Hudson, Ohio
was so convinced that the search for a donor was futile that she helped her
husband buy a suit for her funeral.  "I was bound and determined he was going to
look fine at the funeral," she said. 

Fortunately advances in "alternative sources" of stem cells
have saved Tirpak’s life.  While it is known that stem cells reside in the bone
marrow, another source that is only in recent times being appreciated is cord
blood.  Originally cord blood transplantation was restricted to children since
the number of stem cells per cord is relatively small.  However new advances in
transplantation, as well as introduction of "two cord" approaches have opened up
this procedure for adults.

Dr. Mary Laughlin, founder and medical director of the
Cleveland Cord Blood Center stated "Cord blood is rich in stem cells and easier
to match than adult bone marrow because the immune cells are not developed.
Also, patients can get the treatment in about three weeks — as opposed to six
to eight for bone marrow from an adult donor.  That can be a critical time
interval for a patient who is in remission," she said, noting that doctors often
fear a patient’s relapse while awaiting the transplant.

To get a sense of how difficult it is to find bone marrow
donor matches, the National Bone Marrow Registry has more than 12 million donors
that meet the needs of only about 60 percent of Caucasians in the United
States.  In contrast, only 5 to 15 percent of minorities have available donors. 

Another example of the difficulties minorities face in
obtaining a suitable donor is the story of Nathan Mumford, who is
African-American and was diagnosed with leukemia shortly after finishing
college.  "We went through that process, and nobody had a match. Siblings are
the best matches. My brother or my sister wasn’t a match. My friends, aunts,
uncles, cousins, nobody was a match. So, couldn’t go that route," Mumford said. 
Luckily he too was eligible for a cord blood transplant.  "That was an
opportunity," said Mumford, who survived Hodgkin’s disease as a child. "That was
a chance for me to live. I’m not a quitter. I’ve never been a quitter, so I
wasn’t going to quit."

In November of 2004 he was treated by cord blood
transplantation.  Now his leukemia is cured and he claims he is in great shape. 
I just feel amazing," he said. "I have a lot of energy, and I’m just excited
about it."

The use of cord blood transplants among unrelated donors
have risen from 1 percent in 2001 to 24 percent last year, Dr. Laughlin says.

It should be noted that the use of cord blood for leukemias
is different than its use for other conditions that do not need destruction of
the recipient’s bone marrow.  For example in patients with heart failure there
is a need for stem cells that can either directly give rise to new heart cells,
or produce growth factors that activate stem cells in the heart.  The use of
cord blood derived stem cells for heart failure has yielded some positive
results in animal studies and in several individual case reports as seen in this
video

http://www.youtube.com/watch?v=PcFQeRNuPDo