Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
NCT03899298 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5000
Last updated 2019-08-22
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.
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
- 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.
Sponsors & Collaborators
-
R3 Stem Cell
lead INDUSTRY
Principal Investigators
-
David Greene, MD, MBA · R3 Stem Cell
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-09-01
- Primary Completion
- 2024-03-20
- Completion
- 2029-03-20
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