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Phase 1Not yet recruiting

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

Sponsor
R3 Stem Cell (Industry)
Enrollment
5,000 planned
Conditions
Orthopedic Disorder; Neurologic Disorder; Urologic Diseases; Erectile Dysfunction; Autoimmune Diseases; Renal Failure; Renal Insufficiency; Kidney Diseases; Cardiac Event; Cardiomyopathies; CHF; Pulmonary Disease
Interventions
Amniotic and Umbilical Cord Tissue Procedure
Ages
adults, older adults
Registry
NCT03899298

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Disabilities of Arm, Shoulder, Hand Questionnaire (DASH)
  • Sexual Health Inventory for Men Questionnaire (SHIM)
  • Kidney Disease and Quality of Life Questionnaire (KDQOL)
  • Assessment of Quality of Life Questionnaire (AQOL)

History

  1. Study completion expected

  2. Primary completion

  3. Started

  4. Last registry update

  5. Registered