Presentation by Dr. Huang

MD & Ph.D. Professor and Chairman Xi Shan Hospital Neurosurgery Shi Jing District Beijing.

 

Doctor Huang was much honored to speak for the first time in Europe about his Olfactory Ensheathing Cell therapy.  He therefore thanked the organizers.

Dr. Huang first talked about the generalities of the disease ALS

- Quick and progressive neuro degenerative disorder that leads to paralysis and at a later stage to death

- Between 1 and 9 people out of 100.000 suffer from this disease

- Age of the patients is between 40 and 70 years, with an average age of 59

- The patients only live 1 to 5 years after the establishment of the diagnosis

- The cause of the disease is unknown, for only 2% of the patients, one can speak of a defect in the SOD1 gene.

- Current treatments extend the life expectancy of the patient, but do not cure the disease.

Background OEC transplants

It’s a secure and manageable method that offered partial recovery to already 171 patients with chronical SCI (spinal cord injuries).  It is unclear why the OEC therapy brought progress with these patients

88 patients received a transplant:

- Most were men, that is 65

- Age was between 22 and 77 years, with an average age of 44, 7 year

- The duration of the disease before the surgery varied from 5 months to 12 years with an average of 30, 5 months

- The functions of these patients were measured before the transplant and the results were listed on a scaling form

- After the transplant 70, 1% of the patients got better, 19, 6% were the same and for 10, 3% the disease became worse

In summary and taking into account the ALS scale this means:

- Before the surgery: score 20.69 ± 9, 32

- After the surgery: score 23.96 ± 9, 06

Taking into account the EMG:

- 63 patients improved (71, 6%)

- 14 patients (15, 9%) remained in the same condition

- 8 patients (9, 1%) deteriorated

- No news about the other 3 patients (3, 4%)

The results of 8 of these patients in the longer term, 3 to 4 weeks and 3 to 6 months after the surgery were favorable.  They remained stable and some even improved.  About 2 deteriorated again after 3 to 6 months.  No spinal cord infections, fever over a longer period, reactions on the transplants or mortality were recorded.  The EMG’s showed remarkable improvements.

Video’s

Doctor Huang showed three video’s from patients to show the differences before and after the surgery.  A first man was 48 years and had an OEC transplant after 27 months of disease.  He talked very difficult and was almost unintelligible.  He also walked very difficult and was not able to go to work.   Four weeks after the surgery he was able to talk better and he was intelligible.  He was able to stand up on his own and walk with help.  Only after 14 months his speech deteriorated and he became again less intelligible.  Standing up on his own and walk with help remained.  On slides we saw the EMG’s from before and after the surgery.  We could diagnose that there was an improvement.

A second video showed a 54 year old man who also spoke very difficult and was unintelligible.  He could also hardly open his mouth and his tongue didn’t react as it should.  Three weeks after the surgery he talked better, he could open his mouth and stick out his tongue.  This was also confirmed with EMG’s from before and after the surgery.

The third person was Danny Vyvey, 39 years, from Belgium.  He spoke very difficult and was almost unintelligible.   We had to pay special attention to his feet that dragged while walking difficultly.   Three weeks after the surgery not only an improvement of the speech was detected but he could also lift his feet and walk in a normal way.  Here also the EMG’s showed improvements.

Discussion

- There is a long history prior to embryonic transplants with CNS diseases (lesions in the central nervous system).  Research was already done by different neurologists as from 1989.  The method was used by different doctors, even in the United States.  They even worked with a patients control group that received no treatment.  In China, these practices are prohibited by law.

- The immunity may not be suppressed because of infections and may not cause ‘carcinogenesis’ (problems at the level of the brains?).

- A stabilization of the disease is being detected and in some cases one can speak about a clear improvement.  This stability can last for about 2 years and the improvements remain visible between 6 months and 1 year.    It has to be investigated why the time span is so different with the patients.  Maybe the OEC cells die off by the intervention of the immune system.

Olfactory Ensheathing Cells

The OEC cells are derived from the olfaction of adults and fetuses and from lamina propria.   There are different types of cells, namely bipolar (migration), multipolar (guidance) and “Fried Egg” (support).  In addition, there are also markers such as laminium, LI cell adhesion molecules, Nestin, GFAP and P75 (NGF receptor).

The “OEC myelination of neurites” (development of the myeline scabbard around the neurite) show that some effects and improvements are identified.  That there is a restoration of axon or neurite and of the injured parts in the spine.

Mechanisms for a fast functional improvement and stabilization

Hypothesis: is it possible that the OEC cells change the local environment of the injured areas by producing growth factors and molecules that attach to cells and thus reactivate the latent axons (neurites) and neurons in this way which are damaged but not dead? In experiments it was determined 1, 2 or 3 days after the transplant that there was an improvement in the muscles.  Maybe the surgery provides a growth of new neurons.

Conclusion

OEC transplant is a safe and convenient method that brings an improvement or stability with ALS patients in a quick way and this during a certain period.  Unfortunately it is not a method that provides complete recovery.  We do not know yet why there is an improvement or stability.  It’s therefore a challenge for the future to examine the mechanisms that trigger the improvement or stability.  In addition, it should be verified how this recovery and stabilization can be held as long as possible.

Maybe there should be more cooperation and should the different medical methods be combined.  But there should also be more communication between the different doctors treating.  Essential for the OEC transplants is not only the information about the condition of the patient, but also the follow-up after the surgery.  This way one should be able to come to more reliable results.

Doctor Huang thanked several of his Chinese colleagues, the Chinese government and all his patients for their active support and encouragement.

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