A Fully Iranian Solution to a Complex Medical Challenge

Mothers of children with cerebral palsy are happy that their children now recognize visitors, smile at them, and wave goodbye, and they are encouraged to continue treatment.

According to Ambassador Arjan, Farhikhtegan newspaper wrote: As they say, they do not claim miracles, but they plant hope in the hearts of mothers of children with cerebral palsy. The whole story was nothing but these few sentences. Mothers of children with cerebral palsy were happy that their child now recognizes the guest and smiles at him and waves behind him, and their hearts were warm to continue the treatment. A group of young Iranian doctors and elites, relying on their knowledge and capabilities, have together managed to produce a medicine with cell therapy that both helps in the recovery of children with cerebral palsy and prevents its progress. But this is not the whole story of our honors in drug production. The more exciting news is that Iran is the first producer of this drug and currently in the world market, Iran is the only one that has produced a drug for cerebral palsy patients through cell therapy.

What is the position of Iran in cell therapy?

Cell therapy is one of the advanced fields of regenerative medicine that helps to repair damaged tissues and improve body function by using cells. In recent years, Iran has been able to pass the research stage in this field and reach the production of medical products. According to the announced statistics, out of about 150 approved cell therapy products in the world, nearly 20 products have been produced in Iran and entered the market; A position that places Iran among the top five countries in the world in terms of the number of these products.

Iran's position in this field is not only limited to the production of medical products, and scientific researches also show part of this progress. In the statistics presented about the production of scientific articles in the mentioned field, China ranks first with 136 articles, America ranks second with 25 articles, and Iran ranks third in the world with 22 articles. These figures indicate the scientific capacity of Iranian researchers in the development of regenerative medicine knowledge. Cell therapy applications in Iran cover a wide range of diseases; From cerebral palsy and arthritis to cartilage damage, spinal cord damage, stroke, some blood diseases, chronic diabetic wounds, autoimmune diseases and skin disorders such as vitiligo. However, the level of effectiveness and the status of treatment approval in each of these diseases is different and should be evaluated based on scientific evidence and licenses related to each product.

One of the development paths of this technology is the production of allogeneic products; Products where cells needed for treatment are provided from someone other than the patient. The development of these products can provide the possibility of using cell therapies for a larger group of patients; However, the conditions of use and the need for biocompatibility depend on the type of product and its application. Despite scientific and manufacturing advances, the expansion of cell therapy still requires further research, evaluation of clinical outcomes, ensuring the safety and effectiveness of products, and providing patients with access to approved treatments. Maintaining Iran's scientific position in this field, along with turning research achievements into reliable and available treatments, is one of the most important paths forward for regenerative medicine in the country.

How does cell therapy help children with cerebral palsy?

Cell therapy is one of the methods that has received the attention of medical researchers with the aim of helping to repair damaged tissues and improve body function. But how does this treatment work and what can be expected from it? Ali Salmanian, a doctor and researcher in the field of regenerative medicine, in explaining the mechanism of cell therapy, says that the starting point of this field is to help the body to repair and regenerate itself. According to Salmanian, when one of the organs of the body is damaged, one of the ways of treatment is to use medicine; But in cases where drug therapy alone is not responsive, it is possible to help the damaged cells and provide the basis for their repair and regeneration. This approach is in the field of regenerative medicine and stem cells are one of the tools used in it.

A stem cell can be compared to a mother cell; A cell that has the capacity to help restore and regenerate tissues and can play a role in the healing process of body injuries. Under certain conditions, these cells help to improve the function of the damaged tissue with different mechanisms including the modulation of inflammation. Of course, the type of intervention and the expected result depends on the disease, the patient's condition and the type of treatment. Referring to Iran's position in this field, Salmanian explains that numerous researches on cell therapy have been conducted in the country and significant scientific results have been obtained. According to him, Iran has significant research and treatment capacities in the field of regenerative medicine.

Stem cells from bank to injection

But where do stem cells used in treatment come from and what stages do they go through? In explaining this process, Salmanian points to the stem cells stored in the umbilical cord blood bank. After isolation and preparation, these cells are multiplied and stored in specialized centers and laboratories so that they are ready for therapeutic use if needed. Before using the cells, various tests and investigations are performed, including tests related to microbial contamination and viral agents. The purpose of these checks is to ensure the quality and health of the cells prepared for injection. The place and method of injection are not the same for all patients. According to this researcher, some patients may need an injection in the spinal canal space, and for others, other methods such as intravenous injection should be considered. The choice of method depends on the condition of the patient, the type of disease and his treatment needs; Therefore, a fixed method cannot be prescribed for all patients.

What does cell therapy do in children with cerebral palsy?

One of the areas in which cell therapy has received attention is helping children with cerebral palsy or CP. In this disease, brain damage can be associated with movement problems and disruption of various functions. Salmanian explains that one of the important mechanisms in this field is the role of inflammation in the injury process and the possibility of helping to adjust it using stem cells. According to him, reducing inflammation can play a role in preventing the aggravation of some injuries and provide the basis for improving the patient's performance. Along with rehabilitation, occupational therapy and continuous exercises, this improvement may gradually appear in movement abilities, muscle contraction control, speech, eye contact, balance, walking, and the child's interaction with the family. However, Salmanian emphasizes that cell therapy should not be considered a miraculous method or a definitive cure for cerebral palsy.

The purpose of this intervention is to help improve the patient's condition and make life easier; Not that he expected all the symptoms of the disease to disappear or that all children would respond to the same level. He also explains about the age of children that the results of treatment can be different in different age groups and he believes that children under 12 years old, especially in the age range of five to 12 years, may get better results from this method. However, according to him, age above 12 years does not mean that cell therapy is ineffective and this method may be useful for this group as well. In general, Salmanian believes that even in cases where complete treatment cannot be expected, cell therapy may help to control some traumatic processes and improve the patient's condition. However, its effectiveness depends on the condition of each patient and the evaluation of the results should be done taking into account the clinical conditions, scientific evidence and the rehabilitation process.

The narrative of families who hope for the recovery of their children

Among families struggling to improve the condition of their children with cerebral palsy, treatment does not end only with medication. Years of occupational therapy, daily exercises, heavy rehabilitation costs and the purchase of mobility aids are part of the path these families go through. Now, some of these families hope to see more changes in their children's condition after receiving the cell therapy drug related to cerebral palsy. A change that for them sometimes means repeating a few words, better understanding the environment or doing daily tasks more independently. Shahin Moradi, the mother of one of the children who received this medicine, talks about the changes she observed in her daughter's behavior and communication after the injection.

According to him, his daughter Fatemeh did not repeat words as much as she does today and had more limited verbal communication, but now she tries to speak more words and even repeats the words and phrases she hears while watching TV programs. Moradi says her daughter received chemotherapy this year and since then, the family has noticed changes in her communication abilities. She describes these changes as promising, along with the improvements she's seen in her daughter's understanding and reactions. For a mother who has seen her child's communication limitations before, this effort to repeat words is also important; However, it is still not possible to make a definitive judgment about the extent and durability of the treatment effect without an expert evaluation. Moradi got acquainted with this drug through a specialist doctor whose daughter is being treated by him. Shahin Moradi's wife is a worker and with the follow-up of Fatemeh's doctor, medicine was injected for her daughter for free.

12 years of occupational therapy and hope for further progress

The story of another family whose child received medication related to cerebral palsy tells of a longer road to rehabilitation. Parnia is 12 years old and has been facing quadriplegic cerebral palsy since birth. He has been doing occupational therapy for about 12 years; For 12 years, Pernia's family has worked to improve her motor skills and increase her independence. Pernia's mother says that despite years of occupational therapy, her son has not fully recovered. In the same situation, the doctor's suggestion to use cell therapy drug has put a new way in front of the family so that they may be able to help improve their daughter's condition.

According to Pernia's mother, the family went to therapy with the hope that their daughter's abilities would improve, especially in speech and learning. He explains that the parents of Pernia's friends have seen changes in their children's speech and cognitive abilities after receiving the drug, and they hope that this process can help them learn better and study as well. However, Pernia's mother still has questions about the effect of the drug on her physical abilities and wants to know if this treatment can help improve her daughter's motor status in addition to speech and cognitive changes.

For the Pernia family, it's not just the result of an injection. Their daughter needs occupational therapy for many years to maintain and strengthen her abilities, and continuing this path imposes a significant cost on the family. The mother says that the cost of occupational therapy has increased significantly in recent months; So that each 45-minute session costs about 1,300,000 Tomans. Her daughter needs two 45-minute sessions a day, and this has made the daily expenses of rehabilitation more burdensome for the family.

Pernia's mother explains that before the war, the cost of each session was about 550 thousand tomans, but after Eid, they faced a significant increase. At the same time, he does not deny the difficulty and hard work of rehabilitation specialists and believes that these services are costly due to the specialized and physical nature of the work; However, families whose children require ongoing sessions need additional support to continue treatment. The cost of providing mobility aids is another part of the economic pressure of these families. Pernia's mother says that the device she bought four years ago for about 15 million tomans, now she has to replace it with a much higher cost to buy a similar model. According to him, the price of these devices is not less than 25 million Tomans. Increasing costs of rehabilitation and equipment, along with normal living expenses, make it more difficult for the family to continue caring for a child with cerebral palsy.

These two narratives of recipients of cell therapy drugs related to cerebral palsy show two aspects of the families' experience; A family who talks about the observed changes in their child's verbal communication and behavior, and a family who, after years of occupational therapy, hopes that the new treatment will help their daughter improve further. For families who have been on the path of treating and caring for their child for years, every little progress can be valuable; But along with this hope, stable access to rehabilitation services, the possibility of providing the necessary equipment and accurate evaluation of the treatment results are also important. Cell therapy is a new window to recovery for these families, but as it turns out, the extent of its effect on each child must be determined by medical evaluation and clinical evidence.

Iranian medicine for cerebral palsy; Hoping to recover from the golden years of brain development

Zahra Qalanbar, the CEO of Celltech Farmed Barkat, in an interview with "Farheehtgan" about the cell therapy drug for children with cerebral palsy, tells about the production process of this product in Iran, its therapeutic capacities and the challenges of family access to this treatment. According to him, the production of this drug is the result of research and going through the stages of scientific and regulatory evaluation; However, cell therapy should not be considered a miracle cure that will give the same results to all children.

2 to 5 years old; An opportunity for early intervention

One of the important issues in the treatment of children with cerebral palsy is the time of diagnosis and the beginning of therapeutic intervention. Referring to the importance of the early years of life, Qolnbar explains that children's brains are more flexible during this period, and this feature can provide the basis for better use of therapeutic interventions. According to him, the age range of two to five years is particularly important; Because in these years, the capacity of the brain to form and strengthen neural connections is greater. Of course, early diagnosis and rehabilitation are also important along with treatment, and the result of treatment cannot be attributed to only one factor. These explanations do not mean that the response of all children to cell therapy is the same. The condition of each child, the severity of the injury and his functional status can play a role in the amount of changes after treatment.

From improving movement to strengthening speech and understanding the environment

The CEO of Celltech Pharmed, Barkat, referring to the clinical data of this product, says that one of the areas of interest in the evaluation of the treatment is the changes in children's motor performance. According to him, in some cases changes related to cognitive abilities, speech or understanding of the environment are also considered; However, the rate and speed of changes are not the same in different children. Qalanbar emphasizes that families should not expect a definite and uniform result from cell therapy. The purpose of this treatment is to help improve the functional status of the child and the evaluation of the result should be done according to the conditions of each patient and clinical indicators. According to his explanation, the treatment may require more than one injection, and the number of injections is determined according to the patient's condition and the treatment protocol; Therefore, it is not possible to consider a single prescription for all children or to judge the effectiveness of treatment based only on an individual experience.

production of Iranian medicine for cerebral palsy; From research to the approval of regulatory bodies

Referring to the development path of this product, Qolnbar considers the production of cell therapy medicine for children with cerebral palsy as one of the achievements of the field of cell therapy in Iran. According to him, the studies conducted and the data obtained in the evaluation process have played an important role in attracting the opinion of regulatory bodies and providing the basis for product supply. He believes that the production of this medicine inside the country can create a new capacity for patients to access cell-based treatments. However, the fact that the product is Iranian does not mean the complete absence of foreign raw materials. According to Qolnbar, the main technology of the product was developed internally, but some of the materials used in the production process, including some culture media and enzymes, are still sourced from abroad. At the same time, referring to the experience of developing this product, he emphasizes the importance of continuing research and updating technology; Because the development of cellular products is not only limited to the initial production and requires the improvement of the manufacturing process, quality control, and examination of treatment results over time.

8-hour limit; The challenge of transferring medicine to distant markets

One of the important limitations of this product is the short time to use it after preparation. Qalanbar explains that the drug should be injected within eight hours of preparation; A limitation that makes it difficult to transfer to distant markets and export to other countries. According to him, the company is considering ways to increase product stability and facilitate its storage and transportation conditions. Achieving this goal could increase the possibility of drug access in more remote areas, but until technical limitations are overcome, preparation and injection time will continue to be one of the main considerations in using the product. This issue is particularly important in cell therapies; Because storage conditions and transportation time can affect the quality of the product, and it is necessary to comply with technical requirements in all stages, from production to injection.

cost of treatment; A concern beyond an injection

The cost of treatment is another issue that plays a role in families' access to cell therapy. Qalanber says that the company covers part of the cost of the product from other sources, and the offered price, according to him, is lower than the cost. However, this support alone cannot solve all the economic obstacles facing families. On the other hand, getting the treatment covered by insurance requires going through the relevant steps and making decisions by the responsible institutions, and this process may be time-consuming, as a result, even when a medical product is produced inside the country, the issue of fair access to it is still important. The production of Iranian medicine for children with cerebral palsy can be an important step in the development of cellular treatments in the country. But the value of this achievement will become more apparent when, along with continuing research and accurate evaluation of the results, the possibility of family access to treatment is also strengthened. Cell therapy is not a promise of definitive treatment for all children, but rather a therapeutic capacity whose effectiveness and limitations should be measured based on scientific evidence.