Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Arthritis
• Autoimmune Diseases
• Cardiac Event
• Cardiomyopathies
• CHF
• COPD
• Disease
• Erectile Dysfunction
• Kidney Diseases
• Musculoskeletal Diseases
• Nervous System Diseases
• Neurologic Disorder
• Neuropathy;Peripheral
• Orthopedic Disorder
• Peripheral Nervous System Diseases
• Pulmonary Disease
• Renal Failure
• Renal Insufficiency
• Stroke
• Urologic Diseases

• NCT number: NCT03899298
• Study type: Interventional
• Source: R3 Stem Cell
• Contact: David L Greene, MD, MBA
• Phone: (844) 438-7836
• Email: info@r3stemcell.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2019
• Completion date: March 20, 2029