Is REGENERATIVE Intervention an established Line of Treatment ?
Please note that Regenerative Intervention procedures are investigational and may not result in your improvement or prevent the progression of your disease. The benefit of participating in this procedure is that you will receive a therapy or dose of medication not currently offered as standard medical care. In addition Regenerative intervention is one such research effort to help you to manage the disorder and to increase the quality of life. .
Before trying out REGENERATIVE Intervention:
You will have to submit your required medical records (asked by the Clinician) for evaluation and analysis and whether you are fit for experimental regenerative Intervention.
After assessment of your medical records scientific evidence based Counselling will be done by concerned clinician as per your appointment schedule along with all known risk and side effects of the treatment.
Your treating doctor will decide your therapy module as per the protocol approved for the specific disease by IEC (Institutional Ethical Committee) of the Hospital. Your inclusion in this Regenerative Intervention will be solely depending on the inclusion criteria as per the therapy protocol.
You will be allocated the phone numbers, email Ids concerned doctor, medical coordinator and nurse for future communication if you have any further queries.
It is necessary to carry out certain screening tests such as HIV, HBV, HCV, CMV, and VDRL (Infection Profiles) before Regenerative Intervention. It may be necessary to repeat some of the screening tests if there is a delay in conducting therapy or you opt for longer time for this therapy. If your clinician thinks it is necessary to check your health condition for safety reasons. These additional evaluations may include laboratory tests, pulmonary function tests, or an echocardiogram, MRI, PET-SCAN or any other tests that your clinician feels useful and necessary.
2nd Phase of counselling will be done after getting all of your required test reports, in which the concerned clinician explained the therapy procedure to you and take your official consent to fix the date for your treatment.
At the Time of REGENERATIVE Intervention:
Two days before the therapy you will be admitted in the hospital. Clinician may ask you to do some basic tests before initiate the therapy. These tests will be treated as a base line data before your treatment.
Route of intervention will depend on the type of disease. There are possibilities that in some conditions such as spinal cord injury or any complicated neurological disorders clinician may go for surgical interventions. (As explained to you at your 2nd Phase of Counselling).
In addition to medications given to you as part of your standard medical care.
After REGENERATIVE Intervention:
You likely will be hospitalized until your CBC values are normal and monitor closely by clinician for any adverse reactions if any. This may take at least 2-3 days. You may get discharge and come for second time procedure as per the schedule or you may continue in the hospital until your clinician complete the treatment procedure.
After hospital discharge, you will need to stay in touch to your concerned clinician for another 1-2 months for follow-up visits.
Key Points about REGENERATIVE Intervention:
This treatment may be ineffective in your case
Although we have not observed any serious side effects of Regenerative Intervention till date, though there is a small risk of developing adverse reaction depending on the person.
This therapy will weaken your immune system for some time. You may have to protect yourself against any infection.
You may receive antibiotics to protect against infection and to treat an infection if it occurs.
Regenerative Intervention is off level therapy module. So it is absolutely on your willingness to participate in it or NOT.
Before you decide to participate, it is essential that you have all of your questions answered. (Please read your consent form carefully)
Will your Progress be Monitored ?
Yes, you will be provided detailed schedule for your follow-up visits to monitor your progress after the treatment.
Will your Clinical Evaluation be Done ?
You will have a comprehensive evaluation performed over the first year. You will have to visit 1, 3, 6, 9 and 12month after therapy. Assigned doctor or nurse will contact you by phone to ask you questions regarding your health status.
Assessment of your Quality of Life:
In addition to the follow-up assessments described in the consent form, you will be asked to complete quality-of life surveys. These will be used to evaluate how you feel and how well you are able to do your usual activities.
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