Client/Mother Full Name * Client/Mother Surname * Client/Mother Identity Number * Client/Mother Email Address *
I am the Mother of the unborn child (“my Child”) whose Cord Blood and/or Cord Tissue is to be collected at the time of its birth.
I am entitled and duly authorized to sign this document on behalf of my Child.
I authorize CELVI, and its authorised accredited Processing Laboratory to Collect, Receive, Process and Test the Cord Blood and/or Cord Tissue from the placenta and umbilical cord and to Cryopreserve and Store the Stem Cells contained therein (collectively, “Cord Blood and/or Cord Tissue”) in accordance with the accompanying Client Agreement for Umbilical Cord Blood and Tissue Storage.
Should the Mother be unable to sign due to medical reasons, the Father of the unborn child may sign this consent form.
1. What are Stem Cells?
Stem Cells are the earliest cells of a developing embryo that differentiate to form all the cells of the human body. Researchers have found that Stem Cells remain in our bodies to maintain and repair our organs throughout life. Stem Cells are also found in the blood and tissue of the umbilical cord and placenta of newborn babies, which are normally discarded after birth.
Cord Blood contains blood forming Haematopoietic Stem Cells (“HSCs”) and the main uses of these are in the treatment of the following groups of disease:
• Malignancies (Leukaemia, lymphoma, multiple myeloma, solid tumours);
• Anaemia (Fanconi’s anaemia, sickle cell disease, Thalassaemia);
• Bone marrow failures (Aplastic anaemia, pancytopaenia);
• Immunodeficiency (SCID, Kostmann syndrome, Wiskott-Aldrich syndrome, lymphoproliferative disorder, ataxia telangiectasia, Di George syndrome);
• Inborn errors of metabolism (Adrenoleukodystrophy, Gaucher’s disease, Krabbe disease, Niemann-Pick syndrome, Tay-Sachs disease).
Cord Tissue is rich in Mesenchymal Stem Cells (“MSCs”). MSCs are being employed in research environments for a variety of aesthetic and medical conditions that include:
• Skin regeneration (wound healing and burns, scar remodelling, pigmentation disorders);
• Neurology (nerve regeneration and repair);
• Orthopaedics (cartilage, bone repair);
• Sports injury (tendon, ligament repair);
• Cardiology (heart muscle regeneration);
• Reconstructive surgery (fat grafts); and
• Other possible clinical areas.
2. How is the Cord Blood Collected?
2.1. A Collection Kit is provided for the collection of the Cord Blood, which is taken to the birth of my Child and handed over to the Healthcare Provider that will perform the collection.
2.2. The collection bag is packaged in a sterile manner and needs to be opened on a sterile tray.
2.3. After my Child is born (via normal vaginal delivery or Caesarian section) the umbilical cord is clamped, and my child is safely handed over.
2.4. The Healthcare Provider will clean the umbilical cord with a suitable antiseptic solution to limit contamination, but this does not eliminate this risk. Then the needle of the collection bag is inserted into the umbilical vein of the umbilical cord. The bag will fill with Cord Blood. Once the flow of blood stops, the needle will be removed from the vein.
2.5. The clamps are closed, and a knot will then be tied on the main line of the tubing just above the bag. The Cord Blood bag will be packed into the temperature insulating bag and placed back into the Collection Kit for courier to the laboratory.
3. How is the Cord Tissue Collected?
3.1. Cord Tissue is collected after the Cord Blood is collected and the placenta delivered.
3.2. The Healthcare Provider will clean the cord with a suitable antiseptic to limit contamination, but this does not eliminate the risk of contamination in the final product.
3.3. A 10-15cm (ten to fifteen centimetre) piece of umbilical cord is cut and will be placed inside the tube provided in the Collection Kit to be couriered to the laboratory.
4. Collection Risks and Consent
4.1. I will request that my Healthcare Provider collects the Cord Blood and/or Cord Tissue using the Collection Kit provided by CELVI;
4.2. I understand that, under normal circumstances, collection should never interfere with the birthing process and cause me no discomfort or pain;
4.3. I understand that there may be complications at birth that will make it impossible or problematic to collect the Cord Blood and/or Cord Tissue, and for these reasons my Healthcare Provider would be entitled to refuse to collect the Cord Blood and/or Cord Tissue. I will not hold CELVI responsible for my Healthcare Provider’s decision not to collect the Cord Blood and/or Cord Tissue at the time of the birth.
4.4. I shall have the opportunity to deny or withdraw consent to the procurement procedures without affecting my access to or quality of medical care. As a result of my withdrawal of consent all Cord Blood and/or Cord Tissue, and personal information associated therewith shall be destroyed and/or be discarded in terms of applicable legislation, regulations and guidelines by the Healthcare Facility.
4.5. I understand that there is a risk of bacterial and/or fungal contamination when collecting Cord Blood and/or Cord Tissue.
4.6. The contaminating bacteria and/or fungus is usually a naturally occurring contaminant of the birthing canal. CELVI tests every cord blood unit for these contaminants.
4.7. I understand that the Cord Blood and/or Cord Tissue collected may be insufficient and/or not viable for storage and/or transplantation and/or any other purpose.
4.8. I record and agree that I have been fully informed about the procedure for collecting Cord Blood and/or Cord Tissue and hereby consent to allow my Healthcare Provider to collect the Cord Blood and/or Cord Tissue after the birth of my Child and to furnish it to CELVI for Testing, Processing and Storage.
5. Risks Involved in Storage and Use
5.1. I understand that there are no assurances that any benefits of storing my Child’s Stem Cells will be obtained;
5.2. I understand that the transplantation of Cord Blood Stem Cells and/or Cord Tissue is a relatively new procedure that may offer possible future benefits to my Child and other beneficiaries in treating certain diseases;
5.3. I understand that my Child’s Cord Blood and/or Cord Tissue Stem Cells are stored exclusively for use for my Child or any family member who is an HLA-type match that I, the Mother of the Child or the Child, decides to donate the Stem Cells to;
5.4. I understand that there are several instances in which the use of my Child’s Cord Blood and/or Cord Tissue Stem Cells for herself/himself would not be recommended (for example certain inherited diseases);
5.5. I acknowledge that there are alternative sources of Stem Cells such as bone marrow, peripheral (circulating) blood and adipose tissue, that could be accessed from my child or possibly a suitable matching donor, should I decide not store my Child’s own Cord Blood and/or Cord Tissue Stem Cells;
5.6. Pertaining to Cord Blood Stem Cells only,
5.6.1. I understand that the likelihood of using my Child’s Cord Blood Stem Cells is limited and that it is highly likely that they may never be used;
5.6.2. Even though there is a good chance of a suitable match, I understand there are no guarantees that the Cord Blood Stem Cells will be a match for other family members;
5.6.3. I understand that Cord Blood Stem Cells contaminated by bacteria and/or fungus can be stored, but there is no guarantee that the transplanting physician will accept the sample for transplant which will be dependent on the clinical situation at the time. I acknowledge that we do not know what future medicine will bring and perhaps this contamination will not be an issue in the future.
5.7. Pertaining to Cord Tissue Stem Cells only,
5.7.1. I understand that there is the likelihood that my Child’s Cord Tissue Stem Cells may never be used;
5.7.2. I understand that Cord tissue is processed with antibiotics (specifically including penicillin) and may be exposed to enzymes and other possible allergens during processing, Stem Cell extraction, proliferation and storage. These components are washed out before therapeutic use, but trace amounts may still be present in the final product. Transplant may be contraindicated based on the recipient’s allergy profile. This is based on current known best practice;
5.7.3. If the Cord Tissue Stem Cells are required, I understand that the cord tissue will need to be thawed and the Stem Cells extracted. There is no guarantee on the number and viability of the cells that will be extracted as not all cord tissue yields stem cells that can be cultured, due to patient biological variability. I further understand that additional laboratory work will be required to expand the isolated cells to produce sufficient cells for therapy. In this instance blood serum from the Child may be required to culture the cells and consequently a sample of my child’s blood will need to be drawn for the process. Depending on the specific treatment required, other laboratory work may be additionally required. CELVI doesn’t currently offer this service and the cost of this extraction and culture by another laboratory, will be for my own account, and/or that of my Child.
5.8. I understand that the Cord Blood and/or Cord Tissue Stem Cell harvests are typically low in volume and could be insufficient (without expansion or supplementation) for a transplant.
5.9. I understand that there is a documented and unavoidable cell loss during the Cryopreservation and thawing process, even though the Processing Laboratory uses internationally accepted methodology, we are therefore not able to determine post thaw cell yield at time of Cryopreservation.
5.10. As this science is relatively new, the longest recorded period of viable thawed Stem Cells has been for 23 (twenty three) years (Broxmeyer H.E et al; Hematopoietic stem/progenitor cells, generation of induced pluripotent stem cells and isolation of endothelial progenitors from 21- to 23.5-year cryopreserved cord blood; Blood. 2011 May 5; 117(18): 4773–4777. Pre-published online 2011 March 10. doi: : 10.1182/blood-2011-01-330514), and as such, I understand that there are no guarantees that the Cord Blood and/or Cord Tissue can actually be stored indefinitely.
6. Information Services
6.1. I have received information regarding the risks, benefits, discomforts, and alternatives to Stem Cell Collection, Testing, Processing and Storage.
6.2. I am entitled to donor advocacy services in the form of access to the Processing Laboratory’s medical staff to ask questions and have these answered to my satisfaction. I am also able to ask my own Health Care Provider questions should I need to.
6.3. I have received a written copy of CELVI’s contact information for any questions related to cellular therapy products.
7. Maternal Health Questionnaire
7.1. I agree to fill out the Maternal Health Questionnaire in the Collection Kit and return the form to CELVI with the Collection Kit. I understand that this part of my medical history will be reviewed by the appropriate CELVI and the processing laboratory staff.
7.2. I agree to provide information related to our family’s medical and genetic history, if available.
8. Maternal Blood Testing
8.1. Maternal Blood Testing is required for Cord Blood and/or Cord Tissue Stem Cell storage according to the South African National Health Act (61/2003) Regulation on Stem Cell Banks (Reg 183)
8.2. I understand that I must have a sample of my own blood taken by venipuncture (the usual method for blood tests) within 7 (seven) days prior to delivery or 7 (seven) days after the delivery, in order to be tested for Transmissible Diseases.
8.3. I am responsible for and will ensure that I have my blood sample taken by a Healthcare Provider at the hospital or clinic where I am delivering my baby. The blood sample will be taken in the blood tests tubes provided by CELVI in the Collection Kit.
8.4. I understand that there is a slight risk of bruising, discomfort, inflammation, or infection at the site of the blood draw.
8.5. My blood will be tested for certain infectious diseases, including:
8.5.1. Human Immunodeficiency Virus (HIV) -1 and -2 (AIDS causing virus);
8.5.2. Hepatitis B and Hepatitis C Viruses (viruses that affect the liver causing hepatitis, jaundice and liver dysfunction);
8.5.3. Syphilis (a contagious disease that is characterized by genital ulcers, skin rashes and lesions that can affect all organs of the body).
8.5.4. Cytomegalovirus (a common herpes type virus that goes unnoticed in healthy individuals but can be life-threatening in immune-compromised patients).
8.5.5. Human T-cell Lymphotrophic virus (HTLV I/II) (a sexually transmitted virus that can cause adult T cell leukaemia/ lymphoma as well a neurological disorder such as paralysis of lower limbs. It can also be transmitted via blood or body fluid transmission).
8.6. The Processing Laboratory medical doctors will review the results of the Testing.
8.7. I understand that abnormal results will be reported to me. Should my test results be positive for any of the following: HIV, Hepatitis B or C, HTLV I/II or Syphilis, I will have a confirmatory test done i.e. another sample of my blood will be taken and tested. If these confirmatory tests are positive, the Cord Blood Stem Cells and/or the Cord Tissue will be stored in permanent quarantine with other samples of the same infectious disease. I understand that I will be required to sign an Addendum to this Informed Consent should my blood test positive for the above-mentioned infectious diseases. The cost of the confirmatory blood tests will be for my own account. CMV positive test results will not preclude the storage of the Cord Blood Stem Cells and/or the Cord Tissue.
8.8. I hereby consent to the Processing Laboratory’s disclosure of the results of my blood tests to my Healthcare Provider, to any other Stem Cell storage facility to which I have authorized transfer of the Stem Cells, to the transplantation service in the event the Stem Cells are released for use, and to any government agency to which we may be required to report such results under applicable law and regulations.
9. Cord Blood Testing
I understand that:
9.1. The Processing Laboratory will undertake tests on my Child’s Cord Blood to ascertain the nature, number and viability of the Stem Cells to be Cryopreserved;
9.2. HLA typing for matching, or determining matching, of genetic material to maximize the chances of a successful transplant
9.3. The Processing Laboratory will not release the Stem Cells until CELVI has received the consent form the Parent(s) or Child, an order from the recipient’s transplant or treating physician as well as approval from a medical doctor;
9.4. Reference samples of the Cord Blood will be Stored for future testing of HLA-type, and cell count and viability upon thawing. These are small in quantity and do not significantly affect the overall number of Cord Blood Stem Cells stored.
10. Cord Tissue Testing
10.1. Viability testing will be carried out on the Cord Tissue prior to storage.
10.2. Once the cells are required for therapy and have been removed from storage and the Stem Cells isolated from the Cord Tissue, they will be tested for quantity and quality according to the requirements set by the transplanting facility. Due to rapidly changing clinical practice, the test results may not meet their requirements at that time.
11. Preparation of Stem Cells for Transplant
11.1. Cord Blood Stem Cells may require washing after thawing, for transplantation. They will be transported in either their thawed or frozen state (to be thawed at the bedside) and infused into the patient’s blood stream.
11.2. Cord Tissue requires further preparation for transplant. The mesenchymal rich fraction of the Wharton’s Jelly is stored and as such the Cord Tissue Stem Cells are not extracted from the cord tissue before storage. When required for transplant, the cord tissue will be transferred to another laboratory for the additional work required. There is an additional cost for this laboratory work which will be for my account, and/or that of my Child.
12. Cord Blood Disposal
12.1. If the Cord Blood that is collected has low cell count or low cell viability and is not recommended for Storage according to CELVI storage limits and standards, I will be informed by the processing laboratory about the possible options available to me.
12.2. I have the choice to continue Storage and will sign a disclaimer in order to do so, or if I decide to discontinue Storage I will sign a disclaimer to either donate the Cord Blood for internal research/validation purposes, discard it or donated it to the Sunflower Fund for purposes of therapeutic use for any other person who proves to be a suitable match.
12.3. I understand that CELVI will retain confidentiality of the sample and that the Stem Cells will not be used for any other purposes than those set out in the Storage Agreement and Informed Consent.
13.1. I authorize the Processing Laboratory to Cryopreserve and Store any excess Cord Blood and/or Cord Tissue (that would normally be discarded) and routinely perform validation testing on this, to ensure the ongoing viability of the stored Cord Blood and/or Cord Tissue.
14. Disclosure of Health Information
14.1. CELVI will maintain the confidentiality of my health information that I provide to them concerning myself and my Child.
14.2. I do however understand that Health Care Providers may need such information to provide treatment to me and/or my Child and/or matching relative and that government agencies may be entitled to obtain such information under applicable law and regulations.
14.3. I authorize CELVI to disclose such information to its Processing Laboratory for purposes of Processing, Testing, and storing, as well as my Health Care Providers that are treating me and/or my Child and/or matching relative; and to government agencies as may be required under applicable law and regulations.
14.4. I authorize CELVI to disclose such information for research purposes in an anonymous manner and always maintaining CELVI’s confidentiality obligations in terms hereof.
15. Disclosure of Information
15.1. CELVI may use all data received from the Processing Laboratory and the Client for historical, statistical or research purposes;
15.2. All data referred to in clause 15.1 herein above will be anonymised, de-identified and kept strictly confidential as confidential information;
15.3. CELVI may use all de-identified data and/or datasets of which CELVI is the legal author and has subsequently secured copyright therein for commercial purposes;
16. Warranties and Limitation of Liability
16.1. I confirm that I have read, understood and agreed to be bound by all parts of the Client Agreement for Umbilical Cord Blood and Tissue Storage.
Client/Mother Full Name * Client/Mother Surname * Date *
Date Format: DD slash MM slash YYYY
Client/Mother Signature *