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

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ClinicalTrials.gov Identifier: NCT03899298

Recruitment Status : Not yet recruiting

First Posted : April 2, 2019

Last Update Posted : August 22, 2019

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Sponsor:

Information provided by (Responsible Party):

R3 Stem Cell

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
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	Biological: Amniotic and Umbilical Cord Tissue Procedure	Phase 1

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:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	5000 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	The study will be ongoing for patient inclusion and data acquisition. Patients will be separated into one of seven categories including: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The treatments will not be randomized or blinded. This is a partially patient funded study. The study has been approved by an Alion accredited Institutional Review Board, Solutions IRB as of March 2019.
Masking:	None (Open Label)
Masking Description:	No masking.
Primary Purpose:	Treatment
Official Title:	Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions
Estimated Study Start Date :	September 1, 2019
Estimated Primary Completion Date :	March 20, 2024
Estimated Study Completion Date :	March 20, 2029

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Amniotic and Umbilical Cord Tissue for Autoimmune Conditions Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for autoimmune conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.	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. 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
Experimental: Amniotic and Umbilical Cord Tissue for Orthopedic Conditions Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for orthopedic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.	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. 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
Experimental: Amniotic and Umbilical Cord Tissue for Neurologic Conditions Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for neurologic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.	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. 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
Experimental: Amniotic and Umbilical Cord Tissue for Urologic Conditions Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for urologic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.	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. 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
Experimental: Amniotic and Umbilical Cord Tissue for Cardiac Conditions Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for cardiac conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.	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. 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
Experimental: Amniotic and Umbilical Cord Tissue for Renal Conditions Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for renal conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.	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. 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
Experimental: Amniotic and Umbilical Cord Tissue for Pulmonary Conditions Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for pulmonary conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.	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. 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

Outcome Measures

Primary Outcome Measures :

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
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.
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.
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.
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.
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.
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.
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.
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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899298

Contacts

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Contact: David L Greene, MD, MBA	(844) 438-7836	info@r3stemcell.com

Sponsors and Collaborators

R3 Stem Cell

Investigators

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Study Director:	David Greene, MD, MBA	R3 Stem Cell

More Information

Additional Information:

R3 Stem Cell This link exits the ClinicalTrials.gov site

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Responsible Party:	R3 Stem Cell
ClinicalTrials.gov Identifier:	NCT03899298
Other Study ID Numbers:	#2018/10/11
First Posted:	April 2, 2019 Key Record Dates
Last Update Posted:	August 22, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by R3 Stem Cell:


stem cell therapy umbilical stem cells amniotic stem cells stem cells	regenerative medicine r3 stem cell perinatal tissue placenta stem cell

Additional relevant MeSH terms:

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Musculoskeletal Diseases Alzheimer Disease Nervous System Diseases Peripheral Nervous System Diseases Kidney Diseases Renal Insufficiency Erectile Dysfunction Urologic Diseases Cardiomyopathies Autoimmune Diseases Disease Pathologic Processes Dementia	Brain Diseases Central Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Heart Diseases Cardiovascular Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Immune System Diseases Neuromuscular Diseases

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