The entire process of our stem cell treatment
Patients initially apply for treatment by e-mail or phone. We then explain what stem cell therapy could mean for them and the requirements that have to be met before they can undergo therapy. The next step involves the patient sending his or her medical records (diagnosis and recent blood tests) to the XCell Center. A multidisciplinary team then reviews the patient's medical status and decides whether stem cell therapy will be possible and appropriate.
If stem cell therapy is an option, a detailed treatment plan is prepared and the patient is informed of the costs of treatment, which vary depending on the type of treatment necessary. Once the patient has consented to the treatment plan and costs, an appointment is scheduled for bone marrow extraction. Please note that this is a surgical procedure, so it is important that patients do not take any blood-thinning medication in the ten days prior to the appointment. It is necessary for the patient to consult their own doctor before discontinuing this type of medication.
The treatment procedure
- Bone marrow extraction
- Isolation, analysis and concentration of the stem cells in the laboratory
- Stem cell implantation
- Postoperative care
The entire procedure is performed in compliance with the principles of "Good Manufacturing Practice" and in accordance with the latest technological and medical standards. The risks associated with adult stem cell therapy are low. They are no different from the risks normally associated with surgical procedures. The therapy involves the use of the patient's own cells, so the risk of rejection -as there would be in a cell or organ transplant procedure- is almost nil.
Patients travelling from abroad to Cologne for stem cell therapy are met by an XCell Center employee at the airport or train station and accompanied to their hotel or to the institute. Generally, our patients do not require round-the-clock care, so they stay in a hotel for the duration of their treatment. The transfers from the hotel to the institute and back are organized by the XCell Center.
Bone marrow extraction
Bone marrow is extracted from the hip bone by one of our physicians. This procedure normally takes around 30 minutes. First, local anesthetic is administered to the area of skin where the puncture will be made. Then, a thin needle is used to extract around 150-200 ml of bone marrow. The injection of local anesthetic can be slightly painful, but the patient barely feels the extraction of bone marrow. Once the bone marrow has been extracted, the patient may return to his or her hotel.
Another method of stem cell extraction involves the mobilization of bone marrow stem cells with the assistance of growth factors. The growth factors are injected into the patient and cause the stem cells from the bone marrow to enter the bloodstream. Stem cells can then be isolated from a blood sample. The XCell Center uses this method less frequently, though in some cases it is a good alternative to bone marrow collection.
Isolation, analysis and concentration of the stem cells in the laboratory
The quality and quantity of the stem cells contained in the collected bone marrow are tested in one of our laboratories. First, the stem cells are isolated. Then a chromatographical procedure is used to separate them from the red and white blood corpuscles and plasma. The sample is tested under sterile conditions so that the stem cells which will be administered to the patient cannot be contaminated with viruses, bacteria or fungi. The sample is also tested for the presence of viral markers such as HIV, hepatitis B and C and cytomegalia. The entire process is documented and the concentrated stem cells are not released for administration until all quality criteria have been satisfied.
The cleaned stem cells are counted and vitality checks are made. If there are enough vital stem cells, i.e. more than two million CD34+ cells with over 80 percent vitality, the stem cell concentrate is approved for patient administration. The cells are stored in liquid nitrogen at -196 degrees Celsius until it is time for them to be used.
Stem cell implantation
The method of stem cell implantation depends on the patient's condition. There are four different ways of administering stem cells:
- Intravenous administration
- Administration via catheter using angiography
- Administration via lumbar puncture
- Direct injection into the target area by way of surgery
To treat diabetic feet, the stem cell concentrate can be injected directly into the diseased tissue.
Intravenous administration
Intravenous administration is the most straightforward method. It is used if the cells have to be distributed throughout the entire body. One disadvantage of this method is that the concentration of cells arriving at the target organ is relatively low. This is why intravenous administration is generally combined with other methods. It is suitable for patients with vascular diseases, strokes, spinal cord injuries, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease or Alzheimer's disease.
Angiography
Angiography facilitates the direct administration of stem cells to the target organ. A catheter is inserted into the femoral artery under local anesthetic. A radiologist is on hand to ensure that the catheter is pushed forward precisely to the target organ - e.g. liver, heart or pancreas - where the stem cells are to be delivered. This procedure takes around one and a half hours. After angiography, the patient is monitored at the clinic for several hours. Angiography is used when patients have diabetes mellitus in order to deliver the stem cells straight to the pancreas, or for patients who have had a cardiac arrest or suffer from cardiac insufficiency (weak heart).
Lumbar puncture
The stem cells can also be administered by lumbar puncture into the cerebrospinal fluid in patients with neurological diseases such as Alzheimer's or multiple sclerosis. They are injected between the vertebra at the lumbar vertebra level. There is no spinal cord here, so it cannot be damaged through the treatment. The spinal canal contains cerebrospinal fluid. Since cerebrospinal fluid circulates, the stem cells are transported directly to the damaged tissue in the spinal cord or brain. Lumbar puncture is performed under local anesthetic.
Lumbar puncture is also suitable for patients who cannot undergo angiography as a result of a blocked artery or patients who are at a high risk of hemorrhaging. This method of application is very safe. Adverse effects such as headaches and nausea may occur, but are only temporary.
Surgery
Direct injection of the stem cell concentrate into the diseased tissue facilitates the administration of the maximum concentration of cells. Depending on the region being treated, surgery can involve a general anesthetic and a several-day stay at the institute.
When treating a spinal cord injury, a laminectomy is performed under general anesthetic. This involves opening the affected vertebra and the dura. The stem cells are then injected directly into the damaged tissue with a small needle. The dura and vertebra are then closed and the operation is finished. Patients usually have to stay in the clinic for two to three days after this operation.
The treatment of a stroke patient involves the administration of the stem cells directly into the affected region of the brain. The procedure is performed under local anesthetic via a tiny hole in the skull. A neuro-navigation system then guides a catheter into the infarcted area. It calculates the precise route to the target area, which minimizes the risk of damaged blood vessels. After the procedure, the wound is closed and after only a few days it is invisible. The patient remains in the clinic overnight for monitoring, and is then discharged on the following day.
Information about the risks of surgery
A surgical procedure is always associated with certain risks and side-effects. These include risks relating to the anesthetic and infections, complications when the wound is healing and temporary post-surgical pain. In rare cases, temporary epileptic seizures may occur after brain surgery. Bleeding can also occur on rare occasions. The XCell-Center minimizes surgical risks by using state-of-the-art medical equipment and ensuring strict adherence to hygiene regulations.
Postoperative care
The majority of patients is not negatively affected by stem cell therapy and can normally leave the XCell-Center a few hours after the implantation procedure. Patients who undergo surgery usually stay for one, two or three days in the clinic.
There is a 24-hour patient hotline in case patients have any queries after they have been discharged. The patients also stay in contact with their physician or a patient consultant by telephone or e-mail so that the XCell-Center can monitor their progress. For example, this enables the modification of insulin dosage after stem cell therapy, and the institute is able to provide patients with recommendations for their further rehabilitation.