Stroke Clinical Trial
Official title:
Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions
To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.
The study will be ongoing for patient inclusion and data acquisition. Patients who have
Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions will be
included.
The study has been approved by an Alion accredited Institutional Review Board, Solutions IRB,
as of March 2019.
Depending on the condition, patients may receive a series of therapies via one or more of the
following methods: intravenous, injection, intra-nasal and/or nebulizer. R3 has several "best
practice" therapy protocols that participating practices will follow. Should a patient have
conditions that fall into more than one condition category, he or she can still be included
with the protocols being received for each condition(s).
Here is a specific administration for each condition category:
1. Orthopedic Condition = Injection
2. Neurologic Disease = IV Infusion and Intranasal Procedure. The exception is with
Peripheral Neuropathy, where participants receive a series of injections along with an
IV Infusion Procedure.
3. Urologic = Injection
4. Autoimmune = IV Infusion
5. Cardiac = IV Infusion
6. Pulmonary = IV Infusion plus Nebulizer
7. Renal = IV Infusion
Pre, Intra and Post procedure data acquisition will occur at various time frames up to 10
years. Follow up time-frames will measure changes occurring from baseline post procedure at 1
month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months
and then on average each year, up to 10 years. Patients will pay for procedures, and no
randomization will occur.
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