Stem Cell Injections
Autologous Stem Cell therapies are not approved in Canada but are allowed to be used in a research study like this one. This study involves research.
What is Autologous Stem cell therapy?
Mesenchymal Stem Cells were first described in 1968 as "Self-renewing cells" that could differentiate into bone, cartilage, adipose tissue, tendon, muscle, and fibrous tissue. It is a treatment that involves taking the stem cells from a person's body and injecting the stem cells back to the same person to treat various conditions, including osteoarthritis.
How does Autologous Mesenchymal Stem cells (MSCs) therapy work?
Some studies suggest that MSCs can slow degeneration and regenerate reverses cartilage tissue degeneration. The MSCs secrete chemicals that signal the body for tissue repair and reduce the function of engulfing cells involved in inflammation. Osteoarthritis is a wear and tear condition of the joints; we are studying if MSC therapy can improve pain and function in a joint.
What is the purpose of this research study?
To compare the effect of single intra-articular injection of Lipoaspirate and Bone Marrow Aspirate on pain and functional improvement in the knee and hip joint treatment.
Who is suitable for this research study?
For this study, suitable candidates are adults with osteoarthritis who had unsuccessful conservative pain treatments for osteoarthritis of knee or hip joint for more than 12 weeks. Click below to find out more.
How many encounters are involved?
A single visit and 4 follow-up phone calls, over a period of 360 days.
How many participants will be involved in this study?
There will be 400 participants in this study.
What does the study treatment involve and what is the probability of being assigned to each treatment?
Stem Cells are collected from different tissues. This study will be taking the cells from your fat or bone marrow via simple bone marrow aspirate or lipoaspirate procedures using a health Canada approved device and injecting them back into your joint.
You will be put into a study group by chance (like a coin toss/ like drawing straws). You have one out of two chances of being placed in each group. You cannot choose your study group.
What happens if you agree to take part in this research?
If you volunteer to participate in this study, we will ask you to do the following things to complete the screening process:
Online Pre-Screening: The Study information will be available on the clinic website. You will read the study information online and give an online consent to proceed to pre-screening. You will complete an online pre-screening questionnaire. After completing an online pre-screening questionnaire, you will give an online consent to be contacted by phone for screening procedures and for retrieving your related medical information from your primary physician. You will be directed to or provided with the study Informed Consent Form (ICF). You will be Scheduled for a remote screening visit if you pass the pre-screening questionnaire.
Remote screening: Remote screening will be carried out by one of the Investigators/assigned Designee. During this call, the ICF will be reviewed, and you will have a chance to ask questions before giving your consent to participate in this research study. You will be asked about your current treatments and medical history. Index joint X-ray and CBC blood test referral will be given if needed. You will be asked about your height and weight. Inclusion/Exclusion criteria will be reviewed. If you are a female subject with childbearing potential, your methods of contraception will be reviewed.
You will be mailed a screening logbook to record their pain intensity 5 days prior to the baseline visit.
Baseline Visit (Day 1): The following assessments will occur prior to randomization:
- Review and sign the Informed Consent Form
- Height, weight, and BMI determination
- WOMAC OA Index
- Updated medical history
- Review of your current medications
- Physical examination
- Index joint assessment
- Urine pregnancy test (female subjects with childbearing potential only)
- Confirmation of eligibility (exclusion/inclusion criteria review)
Once your eligibility is confirmed, you will be randomized to one of the treatment groups. Prior to administering the assigned study treatment, your Blood pressure, and pulse rate, and forehead temperature will be evaluated. You will receive a single intra-articular injection of lipoaspirate concentrate or bone marrow aspirate into the joint. You will be monitored for any immediate adverse events for 30 minutes after the assigned study treatment is administered. After administrating the assigned treatment, your blood pressure, and pulse rate will be evaluated.
You will be provided with a logbook to record any adverse events usual and rescue medications. You will be trained to use the logbook starting from Day 1 (Baseline visit).
Remote follow-up visit 1 (Day 14 ± 3 days):
Follow-up visit will be conducted via phone call. Your adverse event record will be reviewed. You will be instructed to return to the clinic in case of tenderness, increased pain, effusion, swelling, or decreased mobility of the index joint for assessment and treatment. Your daily concomitant medications, rescue medications data and changes in medical history will be reviewed.
Remote follow-up visits 2 (Day 90 ± 7 days), 3 (Day 180 ± 7 days), and 4 (Day 360 ± 7 days, final visit).
Follow-up visits will be conducted via phone calls. You will complete questionnaires such as the Western Ontario and McMaster Universities Osteoarthritis Index and Patient Global Impression of Change. Your adverse events record, daily concomitant medications, rescue medications data, and changes in medical history will be reviewed.
You can schedule an unscheduled visit at any time if you feel the need to see the Study Physician.
What are your responsibilities if you take part in this research?
If you take part in this research, you will be responsible to:
- Undergo screening process and enrollment if you qualify
- Follow all the instructions given by the study team and give them any new information about new medications, new medical issues, etc.
- Complete 4 follow up phone calls on days 14, 90, 180, and 360.
- The use of lipoaspirate concentrate and bone marrow aspirate is investigational, and there may be other unforeseen risks to a pregnancy, embryo, or fetus. Therefore, females of childbearing potential must use an effective contraception from 14 days prior to baseline visit to 360 days after intervention. Effective birth control considered for this trial are total abstinence; consistent use of birth control pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam.
- You should immediately contact the investigator if you develop signs of infection like fever above 39.4 oC, redness, swelling and pain in the injected joint.
Are there reasons for which your participation in the trial could be terminated?
Yes, the reasons are: Your continued participation in the trial would not be in your best interest, including any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation; you meet an exclusion criterion (either newly developed or not previously recognized); non-compliance to treatment or procedure; trial termination.
Is this a safe and effective treatment?
Human research studies related to lipoaspirate and bone marrow aspirate have shown a significant improvement in pain and function from baseline visit to the final visit of 12 months. No serious adverse events, like cancer, were reported. However, this is an active research area that is still not fully proven.
What are the risks?
Common side effects are pain and swelling in the injected joint that resolves in 72 hours. The adverse events related to the study procedure using cells taken from your body obtained from bone marrow or fat and blood tests include: pain, syncope, sensory loss from anesthesia leading to injury, bleeding, bruising, infection, anaphylaxis, puncture of a wrong tissue, and failure of cell therapy. Specific risks are fully explained in the consent form. Since lipoaspirate concentrate and bone marrow aspirate therapy is experimental, there may be other risks that are unknown at present.
What are the benefits?
Potential benefits to subjects participating in this trial may include prolonged reduction of pain and improvement in physical function as well as benefits of medical supervision while partaking in a clinical trial. Possible benefits include new knowledge that could be used in future research and clinical management of knee and hip OA.
Are there any alternatives treatments?
Yes. The alternative treatments are exercises, weight control, physiotherapy, bracing, oral and topical analgesics, opioid and non-opioids pain medications, cortisone injections, hyaluronic acid injections, dextrose injections (prolotherapy), platelet-rich plasma injections and orthopedic surgery.
What if you are injured because of taking part in this research?
If you are injured or get sick because of being in this research, call the study doctor immediately. The study doctor will provide emergency medical treatment, or you will be referred for appropriate medical care. However, if you sign this consent form, it does not mean that you waive any legal rights you may have under the law, nor does it mean that you are releasing the Investigator (s), institution(s) and/or sponsor(s) from their legal and professional responsibilities.
Is there a cost for participation?
Your participation in this research project will involve additional cost of 6,000 Canadian Dollars to you for preparation and administration of cell therapy by doctors, nursing costs for monitoring, equipment costs for preparation of autologous cell therapy, and shipping cost. Your health care insurance probably will not pay for all these additional costs. The cost could be claimed as a medical expense.
Is there a refund for the cost to participate in this study?
If you withdraw from the study after stem cell injection is administered, you will not be eligible for a refund. If you withdraw from the study before the study treatment procedure, your money will be refunded.
- Your participation in the trial is voluntary. You may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which you are otherwise entitled.
- The monitor(s), the auditor(s), the Research Ethics Board (REB), and the regulatory authority(ies) such as Health Canada will be granted direct access to your original medical records for verification of clinical trial procedures and/or data, without violating your confidentiality, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form later, you are authorizing such access.
- The records identifying you will be kept confidential and, to the extent permitted by the applicable laws and or regulations, will not be made publicly available. If the trial results are published, your identity will remain confidential.
- You will be informed promptly if information becomes available that may be relevant to your willingness to continue participation in the trial.
If you would like to have further information regarding the trial and want to know whom to contact in the event of trial-related injury, please email Karmyres2019@gmail.com. If you would like to know about your rights as a research participant, please contact the WCG IRB Canada, the Research Ethics Board at 855-818-2289 or firstname.lastname@example.org
If you are interested in enrolling in the study, please click below or call us at 905 278 5158.
You must read the above before continuing to the questionnaire.
Confidentiality and the Collection, Use and Disclosure of Your Personal Information This consent form also tells you about your privacy rights. If you sign this form, you will be giving your permission for the collection, use and disclosure of your personal information for the purposes of this study. If you decide to be in this study, the study doctor and study staff will collect information about you. This may include your name or initials, date of birth, gender, medical history and health-related information such as results of laboratory tests, x-rays, physical examinations and medical records. The information collected from you will be kept for 25 years as required by law. When possible, the information sent to any person or company contracted by the sponsor will not identify you directly. Other indirect identifiers will be used instead. Your personal information will be used to confirm your eligibility for this study, to assess the results of this study for purposes of safety and to meet legal and regulatory requirements. The study doctor and study staff may share and disclose information about you to any persons or companies contracted by the sponsor to have access to the research information during and after the study. The information will be given to Health Canada. Information, including your medical records, which identifies you and the consent form signed by you, will be looked at and/or copied for research or regulatory purposes by the sponsor and maybe looked at and/or copied for research or regulatory purposes by:
- Health Canada;
- WCG IRB Canada.
Absolute confidentiality cannot be guaranteed because of the need to give information to these parties. The results of this research may be presented at meetings or in publications. Your identity will not be disclosed in those presentations. There may be other circumstances where your information may be disclosed if required by law or for your benefit in the event of an emergency. You have access rights to your information and the possibility to correct your information according to local law and procedures. You can discuss this with your study doctor. There is no expiration for your permission. You may take away your permission to collect, use and share information about you at any time by providing reasonable notice to the study doctor. If you do this, you will not stay in this study. No new information about you will be gathered after that date. However, the information about you that has already been gathered may still be used and given to others as described in this form.