Stem cell therapy for stress urinary incontinence

Stress urinary incontinence is the involuntary loss of urine on effort or physical exertion. It is a highly prevalent condition affecting both men and women. Treatment is performed in a step-wise approach involving conservative measures, such as weight loss and pelvic floor exercises, medical treatment with duloxetine and a variety of surgical treatment options.

However, recent restrictions in the use of synthetic mesh and tape have limited the surgical treatment options, leading to the need for new and novel treatment for stress urinary incontinence. Stem cell therapy is a developing medical field and offers the potential to restore normal physiological function of the urethral sphincter.

The effectiveness of stem cell therapy in stress urinary incontinence has been demonstrated in pre-clinical studies, leading to its evaluation in several clinical studies.

This review assesses the current evidence for the safety and efficacy of stem cell treatment for patients with stress urinary incontinence who have failed conservative and/or medical management and have not undergone previous surgical treatment for stress urinary incontinence.

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Twins and Cord Blood Banking

Over the past generation, the number of twin births has increased in the United States, so that compared to the historical baseline there are now over a million extra twins. Since the 1980s, the trends towards delayed childbirth and increased utilization of fertility assistance have raised the twin birth rate from about 2% to over 3% of babies born.

The majority of twins are fraternal, occurring when the mother releases two separate eggs that are both fertilized. The birth rate of identical twins, which occurs when a single fertilized egg spontaneously splits into two eggs, has not changed and is only 1 in 285 pregnancies. In other words, it used to be that half of twins were identical, but nowadays only 1 in 3 sets of twins are identical.
Genetically, fraternal twins are the same as any other siblings, they just happen to be born at the same time. Both fraternal twins and siblings have a 25% of having matching antigen types. That is a 1 in 4 chance of being a perfect match for a cord blood transplant or any other stem cell therapy that requires HLA matching.

The fact that twins share the same womb means that they tend to be smaller babies. Since the 1960s, it has been established that the average birth weight of full-term babies in the United States is about 8 pounds (3.6 kg) and babies smaller than 5.5 pounds (2.5 kg) are classified as low birth weight. However, within the past decade research has changed medical ideas about what is normal for a twin. Singleton babies are expected to spend a full 39-40 weeks in gestation, but studies show that in order to avoid growth restrictions it is best for twins to be born at 37 weeks. The average birth weight of twins born at 37 weeks or later is 5.5 pounds.

Nonetheless, the fact that twins are smaller babies does mean that they have smaller placentas and less umbilical cord blood. Parents of twins are often concerned about cord blood banking: On the one hand they worry that their babies may experience the learning delays that are often associated with early birth and low birth weight, and which can now be treated with cord blood therapy. On the other hand, they worry that the collected cord blood will not be enough to be useful for therapy.

The bank Cryo-Cell has conducted the only study of cord blood collections from multiple births in the setting of family cord blood banking. Since 3 out of every 100 births are twins, for their study they pulled data from their last 300 multiple births and their last 10,000 singleton births. Not surprisingly, the median volume of cord blood collected was 10% smaller in multiple births. The good news was that the cord blood units from multiple births had nearly 4 times more Total Nucleated Cells (TNC) cells and nearly 8 times more CD34+ cells than the minimums required for storage.

The reassuring conclusion of the Cryo-Cell study is that cord blood units collected from multiple births have sufficient numbers of stem cells to treat children for cerebral palsy and other conditions identified in infancy, under current dosing guidelines.


Apratim gets cord blood therapy for autism

Apartim Dey Singha of Kolkata, India, is now four years old. Although his birth was a month premature, as an infant he passed all his developmental milestones on time. It was not until he reached 18 months of age that his parents noticed his communication skills were not progressing like other children.

“We were worried but our local peadiatrician was positive. He asked us to observe him for another six months. We saw no changes in his behaviour.” – Apurba Dey Singha, Apratim’s father

Apratim saw a specialist in Delhi who diagnosed him as having Autism Spectrum Disorder (ASD). Autism refers to a range of conditions characterized by challenges with social skills, repetitive behaviors, speech and nonverbal communication, as well as by unique strengths and differences. Each person with autism presents differently, but has enough of the traits to be recognized as being on the spectrum.

Apratim’s family researched interventions to improve his language skills and tried several approaches. They learned that in 2014, the same year Apratim was born, Duke University launched the first in a series of clinical trials treating autism with cord blood stem cells.

Results from the first Duke trial of cord blood therapy for autism were published open access in April 2017. In that pilot study, participants showed significant improvements in measures of social skills, expressive vocabulary, severity of autism behavior patterns, and eye-tracking response to stimuli. The children’s scores were measured by both parents and clinicians using established behavioral scales developed for autism. The observed improvements appeared within 6 months of cord blood therapy.

In a press release from Duke University, lead investigator Dr Joanne Kurtzberg expressed “cautious optimism” but urged parents not to jump to conclusions:
“Parents of children with autism should not interpret these results as conclusively showing effectiveness of this treatment. There is much work still to be done in much larger, randomized clinical studies before we can draw any firm conclusions about effectiveness.” – Joanne Kurtzberg, MD

Apratim’s cord blood had been stored since birth with LifeCell International, the largest family cord blood bank in India. His parents asked to participate in a clinical trial at Duke, and after a number of tests he was accepted. The therapy took place in the United States in July 2017.

In the 9 months since the cord blood therapy, his father says he has seen significant changes in Apratim. He is communicating more, his cognitive skills have improved, he’s started school, and he likes playing with his friends.

“We were happy that we made a wise decision of preserving our baby’s umbilical cord stem cells at birth in 2014 with LifeCell, which were used to treat my son for autism. Today, we are seeing great progress in terms of development milestones in my son.” – Apurba Dey Singha


Asia’s Cord Blood Story

During the pregnancy with Asia, a friend of ours told us about cord blood banking. We were fascinated with the idea of storing our baby’s newborn stem cells, and we got in contact with Smart Cells International in Italy. They provided us with detailed information on the process and we decided to go ahead to give our child an extra opportunity.

When our baby was born, Smart Cells arranged a courier who delivered the cord blood to their laboratory near London. The cells were immediately cryopreserved and in a few days’ time they advised us of the outcome with all the storage details. Shortly after her birth, we realised that Asia had problems standing up and fell easily.

In the beginning we thought this was normal, but in the following days and weeks, we realised that she was not improving. Even after a few months, she was still struggling. We had noticed that after about 10 steps, she started having difficulties. Even holding things with her hands was complicated as her movements were not fluid. As if this weren’t enough, Asia did not speak, and, generally, she wasn’t keeping up with other children.

We started to worry so we took Asia to different practitioners, but all of them told us that besides seeing physiotherapists and speech therapists, there was nothing much we could do for her. We were told that Asia would most likely need injections of botulinum toxin in the future to help her. We could not accept that; we wanted to do more.

At the age of two, we took Asia to an orthopedist who diagnosed Asia with a mild spastic tetraparesis due to lack of oxygen at birth. He also told us that, while there is no cure as of today for this disease, physiotherapy could help to diminish the inflammation of the muscles. He also suggested that we use the stem cells we had stored at birth.

We therefore called the Italian office of Smart Cells to make them aware of the problem and they told us that in similar cases, other children had benefited from the infusion of their own stem cells. We did, however, need to speak with Duke University of North Carolina, in the United States, to see if it we could have the treatment there. We relied on Smart Cells in Italy to help us with Duke, because of the language barrier. After a few months, arrangements were in place for the treatment and we left for the United States.

At Duke they were so thoughtful, caring and efficient. It was obvious that they had a huge amount of experience. They explained to us that there was a good chance that Asia would benefit from stem cell treatment but that she should continue to do physiotherapy or some type of sport. Everything went smoothly as planned. On the first day we went to the hospital for a check-up (we had already sent an MRI and Asia’s entire medical history) and on the second day the infusion of her cord blood stem cells took place. Asia had no pain or discomfort during the infusion, which lasted about 15 minutes. On the third day, we went back for further checks and they told us that everything was going well. They also explained that in a few months’ time we would see the first improvements, but after just two weeks Asia was starting to speak better, run and climb. It was obvious that she had greater strength in her arms and legs. It was all so amazing and we were so happy!

The improvements continued and seven months later we went back to the orthopedist who is treating Asia and he said he had never seen such improvements in a child with this type of disease; the stiffness had almost completely gone out of her muscles. Even the physiotherapist who was treating Asia before the infusion noticed that her arms and legs were no longer rigid. The therapist told us that Asia no longer required the same type of physiotherapy and that she just needed to practice some sport. All this was happening under our very eyes and we were so happy, we could hardly believe it.

During the first two weeks after the cord blood infusion, Asia experienced pain in her wrists and in her left ankle because the muscles were decontracting and this was somewhat painful.

Duke Medical Center explained that, based on their experience, on Asia’s weight and on the number of stem cells available, it would be advisable to do two infusions a few months’ apart one from the other. They had therefore decided to use only 60% of the cells for the first infusion and asked us to come back for a second infusion later. We returned to Duke Medical Center in February 2018 for a second infusion and, like the previous time, we managed to do everything easily in three days.

Asia is now four years old and she has just finished her second year of preschool and, even though she is the smallest in her class, she has managed to keep up with the other children. Asia is also attending a modern dance course and she participated in the end of the year show. She was so proud and happy, and so were we.

We now hope that Asia will keep on improving and we are grateful to Smart Cells for having given us the opportunity to change our daughter’s future. We are also especially thankful to Nadia Giacomini, Country Manager Smart Cells Italy, who has been so helpful from the beginning to the end of the process. We could not have done it without her.


The Granddaughter Donated Newborn Stem Cells to her Grandfather after a Stroke

The 60-year-old father of Lucie Pínová suffered a serious stroke in September 2018. According to the World Stroke Organization, 1 in 4 adults over the age of 25 will have a stroke in their lifetime. This year, 13.7 million people worldwide will have their first stroke, and 5.5 million of them will die as a result. In the United States, someone has a stroke every 40 seconds.

“Dad had a stroke two years ago, and eight hours later, Mom found him at home in the bedroom. He was conscious, but his condition was very serious.” Lucie’s father was taken to a hospital near Brno, Czech Republic, where he received medication to disperse a clot in his carotid artery. The stroke affected her father’s left cerebral hemisphere, causing significant paralysis and sensory disturbances in the right half of his body as well as the speech center. After a month in the hospital, the doctors told the family they could do no more, that it was time for Lucie’s father to go home or enter a long-term care facility.

“The doctors subsequently told us that my father would remain mentally handicapped, that he would not know us, that he would not be able to live independently and that he would be bedridden.” recalls Lucie.

Lucie did not want her mother’s life to hold nothing but the constant work of taking care of her severely handicapped father.

The family arranged for their father to stay for three months in a rehabilitation institute in Kladruby (east of Prague). There, he got up from his bed and began to undergo physical rehabilitation, learning personal hygiene, dressing himself, and eating with his left hand. He also learned to use a wheelchair and to walk again with assistance.

“I don’t think I would call it an improvement”, Lucie says of the first months of rehabilitation, because she was frustrated that the progress focused on physical skills but not cognitive skills. “He didn’t know the colors, he couldn’t read, he didn’t know the numbers… I definitely wasn’t going to put up with it”, adds Lucie.

In April 2019, Lucie happened to see a TV show Pošta pro tebe, in which a gentleman talked about his improvement after cell therapy. “It simply came to my notice then. I started looking for, studying what and how umbilical cord and blood cells can be used and what they could improve”, says Lucie. She also contacted stem cell clinics in the Czech Republic and in nearby Slovakia. “I investigated all the risks and I was told that his condition could not worsen after the application of these cells,” she adds.

Therapy with both umbilical cord blood and umbilical cord tissue

Less than a month later, the family took their father to a clinic in Slovakia for therapy with newborn stem cells. Lucie explained, “I chose the clinic in Malacky because they use neonatal cells derived from umbilical cord blood and umbilical cord for treatment. Logically, it occurs to me that these cells, because they are new and unworn, will probably be better than dad getting his own, which are simply old”.

The therapy used both hematopoietic stem cells from umbilical cord blood as well as mesenchymal stromal cells from umbilical cord tissue. The cells were administered both by intravenous infusion and by intrathecal injection into the spinal canal.

The first course of therapy used cells from an unrelated donor baby. In addition to the cell therapy, Lucie’s father continued to receive physical therapy with professionals. In late 2019, he stayed for a second course of treatment at the rehabilitation institute in Kladruby; there the staff remembered him from his stay a year before, and stated that he had made tremendous progress. For example, his walking was improved to the point that he did not need support.

Most important for the family, their father’s cognitive skills greatly improved. In his speech therapy, he began to articulate more, and could control his mouth to speak the letters that the speech therapist asked him to pronounce. “I see a shift in routine things he hasn’t done before. When his food crumbs fall, he stops eating and starts cleaning up after himself” noted Lucie.

The second course of therapy at the end of 2019 came from the patient’s granddaughter. Seeing the improvement from the first therapy, a second therapy was considered to push the progress further. But since Lucie was pregnant in 2019, everyone decided to wait for the birth of the granddaughter so that she could donate her blood and tissue cells to her grandfather.

“When we went to Slovakia for the first time, I informed my father that he would have a granddaughter, so he had to try and be motivated to be able to take care of her when she was born. From the first moment I saw the report on TV, I didn’t stop believing that my dad wouldn’t give up. And when I saw that my dad wanted to fight and wanted to live, I didn’t give up and I wanted to have a slightly normal life for him.”

Lucie Pínová’s advice to other expectant parents: “I think that mothers should find out during pregnancy what can be used for preserved umbilical cord blood. You never know what might happen to your family tomorrow or maybe in 10 years and when you may need cells. If I were pregnant again, I would definitely keep my umbilical cord blood.”


Nerea’s Story

Nerea is an eight year old girl who lives in the Spanish town of Burriana in the province Castellón. She suffers cerebral palsy since a few days after birth. Nerea was born premature and she had some respiratory issues in the neonatal ICU, which caused a lack of oxygen in her brain, which led to cerebral palsy. Since Nerea began to grow, certain motor difficulties appeared which required continuous work by the physiotherapists and a great effort for her family. When Nerea turned 5 years old, her parents received information from IVIDA, which talked about the autologous use (self-transplant) of umbilical cord blood stem cells to treat children with cerebral palsy. Victoria, Nerea’s mother, contacted IVIDA after receiving this newsletter. This was in February 2016. From there on, we started working together to try to use Nerea’s cord blood unit, with the aim of helping her to improve the symptoms of her cerebral palsy.

For a few months, we were jointly trying to get Nerea treated in a Spanish hospital. This was not possible, because the Spanish Agency of Medicines and Medical Devices requested that Nerea be enrolled in a clinical trial, something that was not foreseen in Spain within the short term. It must be understood that the infusion with stem cells for the treatment of cerebral palsy is not a transplant, it is still considered an experimental treatment. That is why the Spanish Agency of Medicines proposed a clinical trial. We understood that the response of the Agency was perfectly reasonable. In order to avoid a detrimental delay in the possibilities of Nerea’s improvement, we next suggested that Nerea should be treated by the team of Dr. Joanne Kurtzberg at Duke University. Dr. Kurtzberg is a well-known and internationally recognized key opinion leader in cord blood therapy and she has conducted a randomized clinical trial using autologous umbilical cord blood units for the treatment of cerebral palsy.

We contacted Dr. Kurtzberg’s team, and after several weeks of communication and a lot of work, finally, Nerea received an infusion of her own cord blood stem cells at Duke University Medical Center in the United States. This was in July 2017.

When we started the activity of IVIDA Banco de Cordón in 2009, we did not visualize that we could help a girl with cerebral palsy to improve her quality of life. For IVIDA, this process has been very enriching and satisfying, and it encourages us even more to continue working in this field of umbilical cord blood stem cells.


Emma’s Story: Spina Bifida Surgery With Cord Blood

Little Emma was born in 2015. During the pregnancy, her parents learned that their baby had malformations of the spine. The diagnosis was spina bifida, which was determined at the 35th week of gestation.

“It was the first anniversary of our wedding,” said Emma’s mother Daria, “my husband and I went to an ultrasound scan to see our daughter, and we learned this terrible news. I had never heard of such a disease before. I didn’t even look for any information, as till the birth of my baby, I hoped that the doctors had been mistaken, and my daughter was healthy.

” Subsequently, it turned out that preparing for the birth of a baby with such a diagnosis was rather complicated. “Maternity hospitals refused me one by one,” recalls Daria.

“Only doctors of Maternity Hospital No. 5 in Kiev agreed to perform a caesarean section if we found a neurosurgeon who would immediately operate on my daughter. Pavel Plavskiy was such a neurosurgeon. It was he who said that it was necessary to collect cord blood, because it would help our daughter during the operation.

” There is nothing in the world more important to an expecting mother than the anticipation of holding her new baby. But sometimes, when it becomes known that the baby will be born with congenital malformations, parents have to postpone the time for dreams and focus on the problem.

Daria says that she became obsessed with making sure they did everything possible to help save the life of her new daughter. One task she took very seriously was the responsibility to keep the cord blood collection kit with her in the hospital.

“When I was in the intensive care unit before caesarean section, HEMAFUND cord blood bank couriers brought a container to collect umbilical cord blood. I constantly kept this red handbag in sight, and I was very scared when I had forgotten to take it with me to the caesarean section procedure.” Despite her advanced pregnancy and having an intravenous drip in her arm, she did not even allow the nurse to go and bring the container. She went for the red bag herself. “Then I constantly tried to keep my eyes on this bag during the operation. Even when I saw my daughter, I only thought that the doctors would not forget to collect the umbilical cord blood. I only calmed down when the container with cord blood of my daughter was handed over to the specialists of HEMAFUND.”

A few hours after birth, Emma was transferred to the neurosurgical department of Okhmatdet specialized hospital. The cord blood was delivered there in a timely manner by HEMAFUND.

“The operation was very complicated. There was a hernia on Emma’s spine, into which the roots of the spinal cord sprouted” is how Daria describes it. The surgeon had to place the spinal cord in the correct position and remove the hernia. Recovery after the surgical operation was quick and encouraging enough. In a month, Emma was discharged from the hospital, and the worst was over. Daria feels “sure that everything went so well thanks to the use of cord blood”.

The neurosurgeon Dr. Plavskiy conducted a study in which 39 children with spina bifida received intravenous infusions of their autologous cord blood. This type of surgery is performed almost immediately after birth, and the cord blood was administered in fresh condition. The motivation for giving the cord blood during surgery was to replenish blood loss and stimulate stem cell mediated repair. The children were followed for 16 months after surgery and demonstrated improvement in both range of motion and functions of the pelvic organs.

Today, the only reminders of Emma’s condition are regular medical examinations and some weakness in her legs. Her parents admit that the challenges they face now are mainly because spina bifida is not well known in their community.


Spina bifida is a birth defect in which there is incomplete closing of the vertebrae in the spine and the membranes around the spinal cord during early development of pregnancy. Among the reasons for spina bifida, doctors name folic acid deficiency, a genetic predisposition, the use of certain drugs by the mother, and poorly managed diabetes. Spina bifida is one of the most common congenital defects that lead to disabilities. Serious cases of spina bifida can usually be detected during pregnancy by fetal ultrasound. There is no known cure for the nerve damage caused by spina bifida, but when surgery is performed shortly after birth it can prevent further neurologic damage by closing the opening in the spine and draining any accumulated cerebral spinal fluid.

Birth Tissues for Surgical Repair of Congenital Hernias

Sometimes babies are born with a hernia, which includes any situation where organs protrude through a weak spot in the surrounding muscle or connective tissue. Mild hernias are fairly common but more serious hernias require surgical intervention. The most common hernia in babies is an Umbilical Hernia, which is a bulge under the belly button that occurs in 10-15% of babies and usually closes on its own by the time the child is a few years old.

A Congenital Diaphragmatic Hernia (CDH) only occurs once in 2500 births but is a serious condition. In CDH, a hole in the diaphragm allows some of the baby’s intestines, and maybe the liver too, to move into the chest cavity. If this is not diagnosed during a prenatal ultrasound, it leads to a crisis at birth, when the baby needs to start breathing through its lungs, but the lungs are compressed by the intestines in the chest cavity. Early intervention is critical. Babies born with CDH need surgery to move their intestines back down to the abdominal cavity and close the hole in the diaphragm so that they can breathe properly. These babies can be at risk for brain injury due to a lack of oxygen in the blood. One clinical trial NCT03526588 launched in 2018 at the University of Texas is attempting to ameliorate neurologic injury in these infants by giving them a few small infusions of their own umbilical cord blood stem cells.

Another serious hernia is Gastroschisis, where a hole in the abdominal wall allows some of the baby’s intestines to escape outside its body. This only occurs once in about 5,000 births but requires surgical intervention. In utero, the portion of the intestine that is outside the body, floating in the amniotic fluid, becomes swollen and may become twisted. At birth, surgeons usually cannot just push this swollen intestine back into the abdominal cavity. The repair may have to be performed in stages, and the baby may require a patch to close the gap in the abdominal wall.

A team in Quito, Ecuador, has developed and published a surgical technique where the baby’s own umbilical cord is used to form a patch during surgery to correct Gastroschisis. Surgeon Edwin Ocaña manually introduces the exposed abdominal contents into the abdominal cavity. He then takes a section of umbilical cord, ligates the blood vessels, and filets the cord lengthwise to expose the interior Wharton’s Jelly without disrupting the blood vessels. This filet of cord becomes a patch which is placed with the Wharton’s Jelly against the defect, and is further protected with a hydrocolloid patch on top. The tissue patch is not fixed in place, but is adjusted every few days while the defect is healing. At the Hospital Carlos Andrade Marin in Quito, the neonatal team sees 4 to 6 patients per year with Gastroschisis. The use of an umbilical cord patch enables them to close a large Gastroschisis defect in one step, instead of a series of stages. They find that surgery with an umbilical cord patch results in reduced healing time, decreased reliance on intravenous nutrition, faster discharge from the hospital, and better cosmetic outcomes.

Spina Bifida is a birth defect where the spinal column does not close completely, leaving the spinal cord and nerves exposed or protruding. This occurs once in about 2,000 births but requires surgical correction immediately after birth. We have previously published the story of Emma, a girl in Ukraine who was infused with her own cord blood as a compliment to her spina bifida surgery. Despite surgery, children with spina bifida often have paralysis or limited use of their lower limbs. Research has shown that exposure of the spinal cord leads to progressive neurologic damage over the course of pregnancy. In order to intervene sooner and preserve mobility, the multi-center Management of Myelomeningocele Study (MOMS) NCT00060606 showed that in utero surgery to close the spinal cord leads to better outcomes. Recently, a team at UC Davis in California registered a pioneering 2020 clinical trial NCT04652908 which combines in utero surgery for spina bifida with a patch consisting of a commercially available matrix that has been seeded with placental mesenchymal stromal cells (MSC).

Research is ongoing to expand the use of birth tissues as a surgical patch. The team in Ecuador is studying the properties of the umbilical cord patch in order to make it more readily available and standardized for use in pediatric surgery. Their current procedure is dependent on access to a fresh umbilical cord, and storage of this living tissue would be costly. They are studying the use of a decellularized umbilical cord that is seeded with a secretome containing growth factors. If this yields satisfactory surgical outcomes, it would make the use of umbilical cord surgical patches more widely accessible as an off-the-shelf surgical tool.