Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer Disease
- Arthritis
- Autoimmune Diseases
- Cardiac Event
- Urologic Diseases
- Stroke
- Renal Failure
- Renal Insufficiency
- Cardiomyopathies
- CHF
- COPD
- Erectile Dysfunction
- Kidney Diseases
- Neurologic Disorder
- Orthopedic Disorder
- Pulmonary Disease
- Neuropathy;Peripheral
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will be ongoing for patient inclusion and data acquisition. Patients will be separated into one of seven categories including: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The treatments will not be randomized or blinded. This is a partially patient funded study. The study has been approved by an Alion accredited Institutional Review Board, Solutions IRB as of March 2019.Masking: None (Open Label)Masking Description: No masking.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 20...
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: Orthopedic Condition = Injection 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. Urologic = Injection Autoimmune = IV Infusion Cardiac = IV Infusion Pulmonary = IV Infusion plus Nebulizer 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.
Tracking Information
- NCT #
- NCT03899298
- Collaborators
- Not Provided
- Investigators
- Study Director: David Greene, MD, MBA R3 Stem Cell