Stem Cell Research Protocol
If the patient agrees to participate in the research study, the following information describes what may be involved.
Screening Visit
Initially, the patient will have a consultation with the Principal Investigator or Co-investigator to be screened and evaluated to see if he/she is eligible for the research study. If the patient meets the enrollment criteria, and agreed to participate, he/she will be enrolled in the study.
Prior to any treatment at the clinic, the patient will be given Informed Consent Form. Once the patient has agreed to take part in the study, he/she will be asked to sign the Informed Consent Form. During this visit, we will ask questions about patient medical history, medications that the patient is taking, and baseline signs and symptoms. All relevant laboratory and radiological examinations and tests will be undertaken as per clinical protocol. The patient will be scheduled to return for the baseline visit.
Baseline Visit, Stem Cell Treatment
It is possible that the screening visit and the baseline visit/first administration of stem cells may occur the same day, depending on logistics. At the baseline visit, the patient will undergo initial tests and examinations, before receiving the study cells.
The administration route and the number of therapy session will be dependent upon the research protocol.
Stem cells will be administered under the supervision of a qualified healthcare professional, trained in the study procedures.
To assure safety, the patient will be monitored for adverse reactions during and after each administration. Vital signs will be assessed before and after each treatment. The length of patient stay at the clinic will be dependent upon the research protocol, but will not exceed 6 hours.
Follow-up Phone Calls and Visits
The patient will have a follow-up phone calls and visits to collect the safety and outcome data required by the study protocol. Safety and efficacy assessments will be conducted at specific intervals described in the clinical protocol.
Adverse events will be assessed immediately after the first intravenous/intrathecal administration, as well as after 24 hours, 1 week, 2 weeks, and 1, 2, 3, 6, and 12 months. Physical exams will be conducted before and after each administration, as well as 2 weeks, 3 months, 6 months, and 12 months after the first administration. Clinical labs will be drawn 2 weeks and 3 months after the first administration. Tests and radiological examinations, specific to the protocol, will be conducted 3 months, 6 months, and 12 months after the first administration to evaluate efficacy.
Study coordinator and our team will answer any questions you may have about the program, participation in the study, and the procedures involved at any time during the study.