Stem cell therapy to cure hip arthritis; KGMU Docs Launch Pilot Project

When 26-year-old housewife Sudha started experiencing radiating pain from groin to thigh, she first dismissed it as an outcome of over-exertion and fatigue. The pain, however, increased to the extent that painkillers ceased to give any relief. After being examined, she was diagnosed with avascular necrosis (death of cells) in the right hip, one of the leading causes of hip arthritis.

She had no option but to live with the pain until she opted for stem cell treatment which is being offered at King George's Medical University on a pilot basis. Doctors in the orthopaedic department started using autologous stem cells to regenerate the hip bone a year ago and the effort has given extremely promising results. Their work has been published in the current edition of medical journal called Advances in Orthopaedics.

It may be noted that 16,000 new cases of avascular necrosis are reported each year in India and at least 100 cases come to KGMU. "We took up the most difficult cases of avascular necrosis wherein the cause of cellular death is not known," Dr Ajai Singh, who along with a senior professor R N Srivastava developed the procedure, told TOI.

Known as idiopathic avascular necrosis, this problem usually occurs in younger people and involves both limbs. Also, since the cause is not known, doctors work only to control the symptom which is like a compromise with the disease. As a result, the patient's life is controlled by pain killers that come with several side effects. The final option is to hold a joint replacement surgery which is not recommended in younger patients globally as chances of revision surgery are extremely high.

The patients and attendant families are apprised about the 45-minutes long procedure. It involves extraction of patient's bone-marrow to prepare autologous stem cells (generated from one's bone marrow) and place it over the affected bones under general anaesthesia. The patient is allowed to go home on the fifth day and kept under regular follow-ups. "Preliminary results showed over 50% reduction in pain at the time of discharge and estimated 25% reduction in necrotic area in three month," said Dr Singh who has kept track of all patients in the study.

The beneficiaries vouch for the outcomes. "I had to make a choice between restricted painful life that would worsen each day or the risk of opting for a new procedure. I chose the second hoping for positive outcomes," said Sudha who was operated in December. Engineering student Pawan shared, "Sometimes I felt I would turn into a person with disability. Now, I am sure of a fairly normal life."

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How Does a Sperm Bank Work

With the introduction of IVF, surrogacy and other scientific options for reproduction, a sperm bank is no longer a taboo concept in society. Most of us still are not clear about the exact procedure entitled to a this bank. A detailed prospectus has been discussed in the following.

A lot of cases of infertility have been resolved with scientific methods and the progress that gives us many options for a safe and possible pregnancy, when the natural and traditional methods for conceiving fail. We have come across terms like IVF (in vitro fertilization) and surrogacy, that is literally a womb for pregnancy. Along with these, sperm donation is also a term that is not rare and taboo anymore, which is an important tool in dealing with infertility cases. It has been recognized as an important aspect in the fields of gynecology and human science. In many cases of infertility and many other reasons (which will discussed below) a donated sperm has been used for reproduction.

A sperm bank also known as cryobank, is the place where samples of sperms are stored. These are regulated by the Human Fertilization and Embryology Authority. An advantage of this bank is that the client can ask for a specific genetic structure of the sperm, that they wish the child to have. You can have your call when it comes to choosing how the child should look. Some people also wish to register a known donor, or provide their own donor, which is also known as surrogate parenting. How is this achieved? What is the procedure of legally donating sperm and how does the bank work? All these facts and more have been compiled in the following segment of the article.

Sperm Donation

There are many reasons why people wish to donate sperm. One major reason is to help an infertile couple have a child. Some will donate sperm to keep it safe for the future in case the individual has a job that can risk his life and reproductive ability, like athletes and sportsmen, army and military professionals. These individuals store their sperm so that they can still have their own child in the future. Medical conditions like cancer, future surgeries like vasectomy can also be the reason why men donate sperms and keep them safe. Some other reasons may be financial obligations and responsibilities. Donated sperms also help singles and gay couples who want a child and who will have their own genes. And also for homosexual women who want children, with her own eggs and genes. It is found that 1 out of 8 couples who are infertile use a donor sperm to help conception.

Process of Sperm Donation

Not every one can donate sperms. Though the name may sound very simple, it is actually a long process to finally donate sperm and get it registered. Sperm is only collected from healthy men, after proper application, an appointment and a series of tests. The person willing to donate can contact the bank, most of the time the information can be found on-line. The criteria for donation is: age of 18-40 years, no family history of disease, must be able to provide complete details of family medical history, must be free from any health issues and disease, should be willing to bear with the commitment made to the donation program.

Once you register after meeting the criteria, you will go through the first round of the process. The individual is consulted with an obstetrician and upon agreement, the first sample of semen is collected. The donor may be advised to abstain from ejaculation for at least 48 hours before the first sample screening for the best quality of sperm. It is then put through tests, for healthy quantity of sperms in the sample, testing for HIV and other sexual diseases. This may typically take 2 to 3 months to complete tests and screening.

The collection of sperm sample can be done in the bank's laboratory, or it can also be collected through something known as 'Priority Male Overnight Collection Kit'. By this the donor can collect the sample at home, in specially made sterile containers that are shipped to them and after the sample collection they can ship it to the bank through Fed ex, which is prepaid and arranged for the donor.

Once the screening is complete, and it gives a positive remark, the donor is called again for the second visit, here he can be asked to sign an agreement of consent to the entire donation process. A series of health tests and check ups follow after this for a few months. Many samples of sperm are taken from the donor as these tests progress.

How is the Donated Sperm Stored

Once the sperm is collected, it is handed over to the lab technician. The sperm is frozen, as well as the cells and tissues in the sample. A special liquid may be used to keep the sperm healthy and free from damage during freezing and thawing. This process of freezing sperm is called cryopreservation. He then, stores the sample in special containers called vials, these are thin containers, are sealed and kept in extremely cold temperatures, in containers filled with liquid nitrogen vapor. The temperatures can vary from (-150° C) to (-196° C). The donated sample, is also checked after freezing and thawing, to meet quality standards, like the minimum count of sperm after thawing a sample must be 20 million active or motile sperms per millimeter.

Time Limit of the Stored Sperm

A sperm has no expiry date, as long as it is stored well in aptly controlled atmosphere, it can stay as long as it is stored well. There are reports of sperms being stored for 20 years, which have been used for conception successfully. The only difference between a fresh sperm and a stored sperm is that fresh sperm are alive inside the uterus for 2-5 days, while a thawed and frozen sperm will stay alive for 24 hours.

Using Donor Sperm

After consulting your doctor you can contact the sperm bank. You can choose from the list of banks all over, as the sperms can be shipped easily. You can discuss with the bank its costs and the donor profiles. Though all samples may not have photographs and names, you can still get all physical details and features. This helps people who want to match the offspring as closely to the father. So a specific search is done, to get a sample with characteristics resembling the recipient (father).

Fees and Costs

For the donors, there are no specific fees, there are only certain rules and regulations, every sperm bank has its own norms, so these rules differ, they may include educational qualifications, specific body weight and height, etc. The donor gets an average of anything between $75 to few hundred dollars for each sample of semen. These may vary with each bank. For the recipient too, the costs of purchasing sperm may vary with every bank.

Donor Identity in Sperm Donation

The donor can either provide full details or remain anonymous. If the person wishes to give full details, he can do so. He can also opt for something known as 'ID Consent', which will allow the future offspring to know the donor's name after the child attains legal age (18 years). Even if the donor chooses to withhold the name, he still has to give descriptive details of himself and his family to the bank. The recipients are entitled of these details. He can choose to stay alien to the recipient or the future child forever or as long as he desires. Later if he wishes to change to ID consent, that is also possible. The bank however, is not responsible to track the donor, and also does not guarantee that the donor will be found at any stage. Also there is no rule that forces the donor to meet the future offspring.

Sperm donation and purchasing is a safe method and, has a good success rate. It is a healthy procedure and has helped many couples share the joy of being parents. Understanding this procedure is equally important, so make sure you consider all aspects of this program when donating or even purchasing sperm.

Corneal Blindness: Stem Cells May Provide Alternative Cure

There could be an alternative to corneal transplantation to cure blindness, thanks to collaborative research findings by a research team from India and the US.

The animal studies conducted on the efficacy of using stem cells to treat scarring of whitening of cornea, the central dark portion of the eye, in curing blindness gave positive results, Sayan Basu, consultant corneal surgeon and scientist, LV Prasad Eye Institute (LEPEI), told newspersons on Thursday.

Basu is working along with James L Funderburgh, Professor of Ophthalmology at the University of Pittsburgh School of Medicine in a collaborative research project.

The results of the animal studies have been published on Thursday in the latest issue of the journal Science Translational Medicine. “We found that when the stem cells were applied to damaged corneas, they healed and became clear again within four weeks of treatment while those untreated remained clouded,” he said.

‘Long way’

However, there is still a long way to go. Phase I clinical studies involving 10 patients at LVPEI are currently underway and might take another six months to be completed.

“We still need to figure out whether the same set of desired results could be achieved in human patients and also the required dosage,” Funderburgh, speaking from the US through Skype said.

Second phase 

Phase II clinical trials will have to be conducted. If all goes well, patients might be in a position to gain from this innovation after about three years.

“But, once proved, it will help treating corneal blindness in most cases at nominal cost,” Basu said. At present, the cost of corneal replacement ranges from ₹50,000 to ₹1.5 lakh. There are nearly 1.40 lakh patients in the waiting lists to receive corneas for transplantation in the country now, he added.

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Scientists Create Artificial Human Sperm, Eggs From Stem Cells

Scientists from Cambridge University have created artificial human eggs and sperm for the first time, using human embryonic stem cells and skin cells.

While this process was previously achieved in rats, this is the first time it has been done with humans. The findings were published in the journal 'Cell.'

However, the end result was not working sperm and eggs, but so-called germ cells that could potentially mature to become viable for fertility.

“Germ cells are ‘immortal’ in the sense that they provide an enduring link between all generations, carrying genetic information from one generation to the next,” Azim Surani, professor of physiology and reproduction at the University of Cambridge, said in a press release.

In biology, when an egg is fertilized by sperm, it divides into a group of cells called a blastocyst, which then develops into a foetus or the placenta.

Some cells become stem cells, which can then develop into any cell in the body. Some of these will become germ cells, and will then become sperm or eggs.

The scientists identified a gene known as SOX17, which decides which cells become sperm and egg cells. They then harvested these cells by culturing human embryonic stem cells for five days.

However, this doesn’t mean that men and women can donate any cells instead of sperm and eggs when they visit a fertility clinic – but the scientists hope the experiment will shed more light on the study of human genetics.

The research also gives scientists another way to examine how the environment impacts genes, such as how behavioural factors – like smoking and what we eat – can activate or deactivate genes.

The study of how genes are affected by environmental factors is known as epigenetic, and scientists hope it will give them a better understanding of cancer and other age-related illnesses.

First Stem-Cell Therapy Approved For Medical Use In Europe

The first stem-cell therapy has been approved by European regulators in a major step forward for advanced medicine in Britain. The European Medicines Agency (EMA) has recommended Holoclar, a treatment in which a patient’s own healthy stem cells are used to grow new cells which are then transplanted into the eye.

It is a major step forward for stem-cell therapies which have so far being confined to the lab and clinical trials. Experts predicted advanced treatments will be available on the NHS within a few years.

“This is exciting both because there are no other treatments for this sort of damage to the eye and because this is the first example in which a ‘medicine’ based on stem cells has been approved for use in humans,” Professor Graham McGeown, Reader in Physiology, Centre for Experimental Medicine, Queen's University Belfast.

“Because the cells come from the patient themselves, there should be no worries that the body will reject them as can happen when using a transplant from another person.

“This treatment will only be allowed under carefully defined conditions, however, so that the outcomes can be carefully monitored to see if the treatment works and doesn’t have any unexpected side-effects.”

Stem cells can act as a repair system for the body.

Limbal stem cells are located in the eye at the border between the cornea – the clear front part of the eye - and the sclera – the white of the eye.

Physical or chemical burns can cause loss of these stem cells, resulting in limbal stem cell deficiency, LSCD, a condition that is estimated to affect about 3.3 out of 100,000 people in the European Union and around 650 people in Britain.

Symptoms include pain, sensitivity to light, inflammation, excessive blood vessel growth, clouding of the cornea, and eventually blindness.

In LSCD the limbal stem cells become so diminished that they eyes can no longer make new cells to repair damage.

The new treatment takes a small sample of the patients healthy cornea, removes the stem cells and grows them until there are sufficient numbers to put back into the eye. The cells themselves then repair the damage.

Moorfields Eye Hospital in London has successfully treated around 20 people with Holocar so far in trials.

Prof Chris Mason, from University College London, told the BBC: "This move would enable far more people to access it, you could now prescribe this."

The EMA decision to approve Holoclar will now be sent to the European Commission for market authorization. It will then be up to Nice to decide whether to approve the therapy for use on the NHS.

Dr Dusko Ilic, Reader in Stem Cell Science, King's College London, said: “The therapeutic approach on which Holoclar is based is relatively well established and it was just a question of when it would be approved by regulatory agencies.

“It has been performed in multiple academic institutions around the world, including the UK. I hope that Holoclar is not just an exception, and that many more cellular therapy products will see market in the next year.”

Holoclar, has been developed by the Italian pharmaceutical company Chiesi Farmaceutici S.p.A.

Enrica Alteri, Head of EMA’s Human Medicines Evaluation Division said the decision represented a ‘major step forward’ for stem cell therapies.

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