STEM CELL THERAPY!!

Stem Cell Therapy Procedure

The actual procedure consists of inserting a fistula needle in a peripheral line. Should vene-puncture in the peripheral line not be possible, a central venous pressure (CVP) line in the format of an inner jugular line, a sub-clavian line or a femoral line, depending on the patient’s age, size condition and indication, is inserted into the patient using local anesthesia and a return catheter into the opposite arm." This is done by our qualified ICU doctor / anesthetists. The CVP line is then hooked into an apheresis machine (GAMBRO COBE Spectra) which separates a volume of the patient's blood into 3 parts: Red Blood Cells, White Blood Cells and Platelets. The Red Blood Cells and Platelets are returned to the patient immediately via the machine. A small volume of the White Blood Cells depending on the patient's age, weight, height, size and condition are taken and converted into pluripotent stem cells via a process of Retrodifferentiation (addition of a monoclonal antibody to a particular cell surface contact receptor). These cells are then given a direction to re-differentiate into the required cell type (progenitors). After the require time of incubation, the stem cells are then washed in a GAMBRO COBE 2991 Cell Processor and re-infused into the patient. The whole process takes between 6 and 8 hours. The CVP line is removed an hour later and the patient is then monitored for a period of 24 to 48 hours and then discharged.

Therapy Side Effects

There have been no negative side effects in any of the 86 patients that have undergone this treatment for various diseases. There have been very positive side effects such as the curing of Psoriasis in patients with Aplastic Anaemia. Patients have a higher energy level after the procedure as compared to before the procedure
 
Regulatory Approvals

The procedure is not FDA or EMEA approved as yet. Data from the human studies in Pakistan has been compiled and prepared for submission to EMEA and the FDA shortly.

Patients Treated To-Date

The total number of patients that have been treated using Retrodifferentiated Stem Cell Therapy since March 1, 2005 are as follow:

BETA THALASSEMIA MAJOR

We treated 28 patients in Beta Thalassaemia Major who required between 2 and 7 blood transfusions in a 2 month period with iron overload measured by Ferritin ranging from 1250 to 11,300.  90 days following the treatment their blood transfusion requirements fell to between 1 and 3 transfusions.  Their serum Ferritin levels fell to normal levels WITHOUT the use of any chelating agent such as Desferal or Feriprox.  Their distended stomachs reduced in size indicating organ repair and normalization.  Thalassaemia Major is a genetic disease in which the patient's red blood cells break down.  The only treatment known is to transfuse the patients with cross matched blood.  Transfusion may lead to the patient getting viruses in unscreened blood and additional iron from the donor.  This iron overload is what eventually kills the patients.  Average life of patients is between 7-10 years. 

Thalassaemia Intermedia
This is milder form of Thalassaemia Major.  The patient has recovered without requiring more than one transfusion in a 10 month period.  The patient was sickly and bed ridden every two weeks due to weakness.  10 months later, he has gained weight and does not require any transfusion or chelating agents of any kind. 

Sickle Cell Anaemia
This is milder form of Thalassaemia.  The patient has recovered requiring only one transfusion in a 7 month period.  The patient was sickly and tired every two-three weeks due to weakness.  In this 7 month period, he has gained weight and does not require any transfusion or chelating agents of any kind. 

How long will it be before your technology is available to patients?
Retrodifferentiated Stem Cell Therapy to treat various disorders is available now at Park Lane Hospital in Karachi, Pakistan.   Very shortly there will be another location opened in the Caribbean. Please call or send an e-mail about opening date of the second facility.

I WOULD like to share my concerns, both as physician and bioethicist, about an advertisement that appeared in a section of the press last week. A private company has advised hospitals that it has machines available for stem cell therapy to treat thalassaemia and other diseases by employing oretro differentiation technology.

With its choice of words, intentional or otherwise, this advertisement is liable to lead lay people to the mistaken conclusion that a cure has been found for thalassaemia (and other unnamed diseases).

At the same time, it lays open the door for unwitting and unscrupulous healthcare professionals to exploit this public misunderstanding.

In the absence of ethical guidelines, negligible oversight processes at institutional and national levels, and lack of regulation of healthcare services, it is not difficult to imagine a proliferation of clinics and hospitals promising desperate patients treatments for all manner of illnesses by using stem cells.

Another concern is that it adds to the hype, generally nurtured by commercial interests, that presents stem cell biotechnology as the panacea for all human ills. Recent advances in adult and embryonic stem cell research hold great promise, but their translation into safe clinical application is some years away.

This is not to imply that in specific areas stem cells are not already playing a part in treating certain diseases. As an example, following years of carefully controlled clinical trials, adult stem cell (bone marrow) transplantation is accepted as a therapeutic modality for acquired conditions such as leukaemia and certain blood disorders.

Thalassaemia, on the other hand, is a genetic disorder, and any measure that does not alter the inherited genetic defect cannot be considered therapeutic in nature. To date, there is no research, let alone clinical examples, or scientific publication, that I am aware of in which this has been accomplished using retro- or de-differentiated adult stem cells.

Controlled clinical research trials are under way in some countries to test adult stem cell capacity to repair/regenerate heart muscles and nerve tissue. But these are clearly categorized as research, not presented as established therapy. These trials are undertaken only after rigorous review and approval by institutional research committees, require full disclosure of the nature and risks of the research to the patient, and his or her voluntary consent to serve as subject for the study.

None of these mechanisms are in place in Pakistan, leaving our public at great risk of exploitation.

DR FARHAT MOAZAM
Professor and Chairperson,
Centre of Biomedical Ethics and Culture, SIUT,
RKarachi

THIS has reference to Dr Farhat Moazzam’s letter “Stem cell therapy” (Sept 24).

I am disappointed at the attitude of senior medical healthcare professionals towards the introduction of cutting-edge, innovative and low-cost medical technologies that may alleviate suffering and benefit patients for whom there is very little hope in conventional medicines/medical treatments.

I am particularly surprised at the “grave concern” expressed by Dr Moazzam on the advertisement placed in Dawn on Sept 11. Not one of the doctors and/or professors of medicine who have been criticizing the pioneering new, patented and validated technology, including Dr Moazzam, appear to have made the effort to actually contact the doctors involved in the project or directly to get further information on retrodifferentiated stem cell therapy and its benefits.

None of the eminent doctors have gone to TriStem Corporation’s website (www.tristemcorp.com) or Google.com (search word “Ilham Abuljadayel”) to try and get information on the history of this technology and/or the scientific research conducted by Dr Ilham Abuljadayel since 1990. Instead, they are criticizing a revolutionary technology and may be discouraging terminally-ill patients (with no conventional medical options) to look at stem cell therapy.

At no point in time have any of our advertisements claimed a “cure” for any/all diseases. We have advertised a “treatment” of diseases in which conventional medicine has either been ineffective or does not have a treatment.

In Beta Thalassaemia Major, a genetic disorder for which Dr Moazzam has claimed that nothing is possible using retrodifferentiation, our results (verified by two independent laboratories including the Aga Khan University Hospital Lab) show a significant decrease in transfusion requirements and a drop in iron load as measured by Serum Ferritin “without” any chelation within a period of 1.2 weeks.

In every discussion with inquiring patients, we have advised all parties involved on the nature of this new treatment.

We plan to present the benefits of retrodifferentiated stem cell therapy and the results obtained thus far through an open seminar for all concerned to be held in Karachi very shortly and publish the findings to-date in the appropriate forum.

TARIQ MUMTAZ
Karachi

Stem cell therapy

For the first time, more than 25 thalassaemic patients in Pakistan were recently treated with their own stem cells, reducing the blood transfusion frequency and lowering their iron overload considerably.

Dr Ilham Saleh Abuljadayel — a Saudi-born, UK-based cellular biologist — and Dr Huma Qureshi, director of the Pakistan Medical and Research Council, last week made public the findings of the study, involving a total of 28 patients, at the Orthopaedic and Medical Institute (OMI) in Karachi.

On the occasion, Dr Ilham said the autologous stem cell therapy introduced reduced the dependence of thalassaemic people on blood transfusion by up to 70 per cent, without the need for an HLA matched donor, growth factors and invasive surgery.

“We have witnessed significant reduction in their (patients’) iron overload as measured by serum ferritin by between 15 and 50 per cent without the use of any form of chelation in a span of 4 to 12 weeks,” she said.

The stem cell therapy Dr Ilham has devised is presently being applied to treat aplastic anaemia, leukemia, sickle cell anaemia, spinal cord injury, type-I diabetes, muscular dystrophy, Alzheimer, Parkinson’s disease, multiple sclerosis, motor neuron disease and heart disease.

According to Dr Ilham, a team of doctors at OMI has applied the stem cell technology to a 24-year-old diabetic girl, who started synthesizing her own insulin within four weeks of the treatment. “It is amazing as her insulin requirement dropped significantly and her eczema disappeared too.”

President Pervez Musharraf was the chief guest at the reception at which the new treatment was formally introduced to the media as well as the medical community.

Hey Danielle and Sharmin,You are wlcome to Pakistan anyway,
Just land here and we girls will have fun 

I know i am posting too much about this, but i am just trying to find a ray of hope.