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NCT03899298Not yet recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 22 Aug 2019 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
5000 (estimated)
First submitted
27 Mar 2019
Start date
1 Sept 2019
Primary completion date
20 Mar 2024
Lead sponsor
R3 Stem Cell
NCT number
NCT03899298

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 5000
  • From 1 Sept 2019 to the primary completion date, 20 Mar 2024
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active Cancer
  • Severe Clotting disorder
  • Myocardial Infarction less than six months ago.

Other

  • Pregnancy, Lactating

Who the study is looking for

  • Age 18 and over.
  • Ability to attend follow up visits or at least converse on phone or complete email follow up forms.
  • Competent to understand the study protocol and provide voluntary informed consent.
  • Patients with any of the following conditions: Arthritis (Degenerative, Rheumatoid, Psoriatic, Lupus, Gout), Sports or Overuse Injuries (e.g. Rotator Cuff injury, Tennis Elbow), Chronic Kidney Disease (may be on dialysis), Back/Neck Pain, Erectile Dysfunction, Peyronie's Disease, Alzheimer's Disease, Parkinson's Disease, Neuropathy, Post-Stroke, Post-Concussion Syndrome, COPD, Emphysema, Pulmonary Fibrosis, Post myocardial infarction (at least 6 months out), Cardiomyopathy, Congestive Heart Failure.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.