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NCT Number: NCT03899298

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

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.

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Key information

Conditions

Orthopedic Disorder Alzheimer Disease Arthritis Autoimmune Diseases Brain Diseases CHF COPD Cardiac Event Cardiomyopathies Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Dementia Disease Attributes Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Heart Diseases Immune System Diseases Joint Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neuritis Neurocognitive Disorders Neurodegenerative Diseases Neurologic Disorder Neuromuscular Diseases Neuropathy;Peripheral Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Pulmonary Disease Pulmonary Disease, Chronic Obstructive Renal Failure Renal Insufficiency Respiratory Tract Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Stroke Tauopathies Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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:

  • Orthopedic Condition = Injection
  • 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.
  • Urologic = Injection
  • Autoimmune = IV Infusion
  • Cardiac = IV Infusion
  • Pulmonary = IV Infusion plus Nebulizer
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Amniotic and Umbilical Cord Tissue Procedure

Biological

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

Other names: Amniotic and Umbilical Cord Tissue Infusion, Amniotic and Umbilical Cord Tissue Nebulizer, Amniotic and Umbilical Cord Tissue Injection, Amniotic and Umbilical Cord Tissue Intranasal

Primary outcomes

  1. Disabilities of Arm, Shoulder, Hand Questionnaire (DASH)

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    Upper Extremity Outcome Instrument

  2. Sexual Health Inventory for Men Questionnaire (SHIM)

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.

  3. Kidney Disease and Quality of Life Questionnaire (KDQOL)

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    Renal Function Outcome Instrument. Raw, precoded numeric values for 36 items are transformed linearly to a 0 to 100 range, with higher scores reflecting better quality of life.

  4. Assessment of Quality of Life Questionnaire (AQOL)

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    General Health Outcome Instrument. Each instrument is used to derive a simple psychometric score for health related quality of life (HRQoL) and to provide profile scores on the different dimensions or items of the descriptive systems. The score is derived by adding the unweighted response order of each question, with a lower score denoting a better quality of life.

  5. Clinical Chronic Obstructive Pulmonary Disease Questionnaire

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.

  6. Mini Mental State Examination (MMSE)

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.

  7. O'Leary/Sant Questionnaire

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.

  8. Oswestry Low Back Pain Disability Questionnaire

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.

  9. Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    Time frame: 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, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months.

    Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best).

Study contacts

Contact information is provided by the study sponsor or research team.

David L Greene, MD, MBA

CONTACT

[email protected]

(844) 438-7836

Sponsors and collaborators

Lead sponsor

R3 Stem Cell

Industry

Registry information

Official study title

Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions

Important dates

Study start
2019
Primary completion
2024
Study completion
2029
First posted
Apr 2, 2019
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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