3. Mr O complains the Trust did not properly inform him of the risks and severe side effects of a stem cell transplant procedure. He complains this means he was not able to give fully informed consent.
4. Mr O tells us as a result of this procedure his Multiple Sclerosis (MS) has accelerated and he has had to stop working.
5. Mr O would like service improvements, the trust to be held accountable for its mistakes, an apology and a financial remedy.
6. Mr O was diagnosed with MS in 2017. MS is a condition that affects the brain and spinal cord, which can cause a range of symptoms including fatigue, vision problems, issues with coordination, numbness or tingling, muscle cramps or spasms and stiffness.
7. In 2023 his symptoms were worsening so the Trust suggested he undergo a stem cell transplant. Stem cells are cells produced by bone marrow (a spongy tissue find in the centre of some bones) which can turn into different types of blood cells. A stem cell transplant involves destroying damaged blood cells and replacing them with stem cells. The transplant happened in October 2023.
8. Since the transplant Mr O has experienced severe side effects, and he says it has accelerated his MS. The side effects he has experienced include paralysis, temporary blindness, a further reduction in his mobility and extreme pain.
12. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not seen any indication that something has gone wrong here. We have explained why below.
13. The FACT-JACIE guidelines outline what is required to gain informed consent for stem cell procedures. These guidelines say that informed consent should be obtained and documented by a licenced health care professional who is knowledgeable in the proposed cellular therapy. It also says this process should include information regarding the risks and benefits of the proposed therapy.
14. The HTA Code of Practice gives a detailed guidance on obtaining consent. These guidelines say that valid consent must be given voluntarily, by an appropriately informed person who has the capacity to agree to the procedure. This person should understand what the activity involves, and the material risks. The guidelines do not specify how this consent should be given or recorded.
15. The HTA Code of Practice says that consent is only valid if there is proper communication and the person has a reasonable understanding of what is being explained to them. Any consent given should be clearly documented. This could be verbal consent which is documented in the patient’s records or in written form.
16. The GMC guidelines say that medical practitioners must give patients the information they want or need to make a decision. This should include the diagnosis and prognosis, uncertainties about these and options for further investigations, and options for treating or managing the condition.
17. It should include the nature of each option, what is involved in each and the desired outcome. It should also include the potential benefits, risks of harm, uncertainties about the likelihood of success and the option to take no action. By ‘harm’ the guidelines are referring to any potential negative outcome, including a side effect or complication.
18. The records show the Trust considered Mr O case at a Multidisciplinary meeting (MDT) in May 2023, and felt his MS was active and progressive. (MS can be relapsing remitting, where symptoms get worse and then get better, or progressive, where symptoms are there all the time and slowly get worse.) The Trust sent Mr O a letter after this meeting which discusses stem cell transplant (AHSCT) as a treatment option. The letter says there are higher risks with this treatment, and it says the treatment may not guarantee to improve his symptoms.
19. We can see Mr O attended a consultation in May 2023 where the doctor recorded they discussed Mr O’s treatment options. The records show Mr O enquired about different medication options, but these were not available on the NHS. The doctor recorded they explained there was no guarantee the AHSCT would halt the progress of his MS or improve his symptoms. The record also says the doctor explained the risks involved and briefly discussed the procedure. It is documented Mr O was open to considering it.
20. The Trust referred Mr O for discussion at another MDT specialising in AHSCT, where the Trust felt he was eligible for the treatment. It referred him to Haematology for further discussion.
21. The Haematologist reviewed Mr O in July 2023. The clinic letter following this appointment clearly explains the procedure. The letter says Mr Stoke understood this therapy was an ‘immune reset’ which is not able to cure MS or to reverse previous neurological damage. The letter also shows the Haematologist discussed the transplant process and risks. They explain the risks of infection, and that symptoms can initially worsen. The letter says that Mr O indicated he was aware of the risks but was keen to proceed.
22. We can see that Mr O underwent the stem cell collection procedure in August 2023.
23. Prior to the transplant Mr O attended a consultation with a Bone Marrow Transplant (BMT) specialist nurse. The nurse documented they gave Mr O written information on Eating with Neutropenia. Neutropenia is a condition characterized by an abnormally low count of neutrophils, a type of white blood cell essential for fighting bacterial infections.
24. It is also documented Mr O was given information on Lymphoma-Autologous stem cell transplant. An autologous stem cell transplant (ASCT) for lymphoma is a medical procedure that uses a patient's own healthy stem cells to replace those destroyed by high-dose chemotherapy.
25. It is also noted the Trust gave Mr O information on Aplastic Anaemia Anti Thymocyte Globulin (ATG) patient information. ATG is a primary, intensive immunosuppressive treatment for acquired aplastic anaemia, designed to stop the immune system from destroying bone marrow stem cells.
26. Our adviser has said there were no MS specific information booklets to give at this time. They have said the side effects described in the literature which is now given would be the same as described to Mr O. There is an additional risk of worsening symptoms during times of infection. We can see the Trust discussed this additional risk with Mr O at other consultations.
27. Mr O completed a written consent form in October 2023. The consent is for Cyclophosphamide/ATG conditioned autologous Peripheral Blood Stem Cell (PBSC) transplant for MS. Our adviser has confirmed that all relevant side effects and risks are listed on this consent form. These are in line with the explanations the Trust noted it gave in previous consultations.
28. Our adviser has said Mr O was provided with all the relevant information to provide valid and informed consent. The clinical team countersigned the consent form to indicate it was happy Mr O understood the risks and could proceed with the procedure.
29. We can also see the Trust has documented that Mr O ‘feels he understands the process that is coming, has read a lot’. This was documented around four days after the Trust obtained written consent from Mr O, and six days before the cells were returned to him. Our adviser said this suggests Mr O still understood the procedure and his consent had remained valid to the point of transplant.
30. It appears that the information the Trust provided to Mr O prior to his stem cell transplant was in line with guidelines set out in paragraphs 13 to 17.
31. We can see Mr O had consultations with a range of healthcare professionals with knowledge and experience of the proposed treatments, who obtained consent from Mr O. Our adviser has said the healthcare professionals demonstrated a knowledge of the procedure during the consultations and had adequate knowledge and experience to obtain consent. This appears to be in line with the FACT-JACIE guidelines.
32. We can see Mr O had more than one consultation where the risks of this procedure were discussed and it was clear the procedure was not curative. Mr O was also provided with written information, that although was not specific for MS, was appropriate for the treatment provided. The written consent form also covered all risks as well as the likelihood of different treatment outcomes.
33. Our adviser said the signed consent for corroborates closely with the information the Trust documented it shared in the consultations. These actions appear to be in line with the HTA Code of Practice and GMC guidelines.
34. We acknowledge Mr O’s condition has deteriorated since the treatment and we recognise how difficult this has been for him. It appears the Trust took sufficient action for Mr O to provide informed consent. We have not seen any indication of a failing in the Trust’s actions here, so we will not be considering Mr O’s complaint further.
35. We understand that Mr O will be upset by this decision. We are sorry to hear of his experience. We do not mean to diminish the distress he and his family have experienced because of his symptoms progressing.
1. We have carefully considered Mr O complaint about St George’s University Hospitals NHS Foundation Trust (the Trust). We are sorry to hear of Mr O ongoing health problems and the impact this has had on him.
2. We have seen no clear indications the Trust did anything wrong when informing Mr O of the risks and side effects of a stem cell transplant. We have therefore decided to take no further action on the complaint.