NCT03899298

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: R3 Stem Cell · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Amniotic and Umbilical Cord Tissue Procedure	Amniotic and Umbilical Cord Cell Therapy with protocols dependent on the patient condition. Protocols include options for IV, Injection, Intranasal and/or Nebulizer.

Timeline

• Start date: 2019-09-01
• Primary completion: 2024-03-20
• Completion: 2029-03-20
• First posted: 2019-04-02
• Last updated: 2019-08-22