Frequent Aksed Questions
Management plan for patients
Yes. Currently we are developing several clinical trials with stem cells but, as you can imagine, only Spanish citizens are allowed to participate.
When a patient from other country requests this kind of therapy we can perform it as a compassionate use.
First of all, we would need a summary of your medical history and fistula current situation, your GI doctor or colorectal surgeon could provide it. Do you suffer Crohn´s disease?
Usually our patients can go home/hotel in the day. If it is necessary we would recommend one day of hospitalization to receive intravenous analgesia.
You should stay in Spain at least two days more after the operation, to be sure you travel in perfect conditions.
Not diet restriction, only laxative to avoid retention of faeces and analgesics will be needed.
Normally wounds close 1 month after operation, but the healing process last four months, sometimes more. We cannot ensure the success or not until 4 or 6 months. If the first procedure does not success, a second one can be schedule.
Usually, with two procedures with stem cells therapy 70% of cases are successful; so probably you will need two visits. In some cases only one visit, including stem cell therapy treatment, is necessary. If after two administrations the fistula persist, the procedure can be repeated with the same probability of success. A follow-up visit may be necessary depending on your symptoms, but you can also be followed by tour local surgeon in coordination with us.
There are two type of cells we can use, autologous (cells belong to the patient and a liposuction is required first) or allogenic (from donor).
If autologous cells are going to be used:
Preprocedure and preop may be ready the day before of the surgery.
The first procedure consists in a liposuction early in the morning, then the vasculo stromal fraction will be extracted and injected in a second procedure in the afternoon after a standard operation over the fistula.
Stem cell processing starts here. Cells will be cultured in the laboratory in order to have as much millions as we can, just in case you need a second dose. Cells injected in the first surgery are just isolated, they are not grown because we obtain the fat in the morning and inject the cells in the afternoon.
If allogenic cells are going to be used (most of the cells we use now are allogenic):
An exam under general anesthesia will be performed and, after a deep curettage of the fistula, donor cells will be injected in the area. These are cultivated cells and this is the option we recommend you at this moment because it is more effective and in one step and could be repeated if needed.
On the other hand, currently we have two allogenic stem cells format available: alofisel (darvastrocel) commercialized by Takeda and allogenic stem cells produced by some Spanish laboratories (Academic stem cells). We have been using both but at this moment we are resolving some regulatory affairs and the use of academic stem cells is delayed, by contrast alofisel is available currently.