Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
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| ClinicalTrials.gov Identifier: NCT03899298 |
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Recruitment Status :
Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
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Sponsor:
R3 Stem Cell
Information provided by (Responsible Party):
R3 Stem Cell
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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 |
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 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 |
| Actual Study Start Date : | March 20, 2019 |
| Estimated Primary Completion Date : | March 20, 2024 |
| Estimated Study Completion Date : | March 20, 2029 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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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.
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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:
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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:
|
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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:
|
|
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:
|
|
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:
|
|
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:
|
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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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.
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
| Contact: David L Greene, MD, MBA | (844) 438-7836 | info@r3stemcell.com |
Locations
| United States, Arizona | |
| Integrative Medical Center | Recruiting |
| Scottsdale, Arizona, United States, 85254 | |
| Contact: Rainer Fischer, ND | |
| Principal Investigator: Rainer Fischer, ND | |
| United States, California | |
| Advanced Stem Cell Institute | Recruiting |
| Encino, California, United States, 91316 | |
| Contact: Pejman Shirazy, MD | |
| Principal Investigator: Pejman Shirazy, MD | |
| Regenerative Medicine Research Institute | Recruiting |
| San Gabriel, California, United States, 91776 | |
| Contact: Zhenghong Yuan, MD | |
| Principal Investigator: Zhenghong Yuan, MD | |
| United States, New York | |
| Frid Institute of Regenerative Medicine | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Elena Frid, MD | |
| Principal Investigator: Elena Frid, MD | |
| United States, Oregon | |
| A New Way Clinic | Recruiting |
| Portland, Oregon, United States, 97219 | |
| Contact: Tal Cohen, DAOM | |
| Principal Investigator: Tal Cohen, DAOM | |
| United States, Texas | |
| Neurosensory Center of Austin | Recruiting |
| Austin, Texas, United States, 78378 | |
| Contact: Kendal Stewart, MD | |
| Principal Investigator: Kendal Stewart, MD | |
| Austin Regenerative Therapy | Recruiting |
| Austin, Texas, United States, 78731 | |
| Contact: Khan Nguyen, MD | |
| Principal Investigator: Khan Nguyen, MD | |
| Atlas Medical Center | Recruiting |
| Irving, Texas, United States, 75062 | |
| Contact: Dr. Alex Schnee, DC | |
| Principal Investigator: Alex Schnee, DC | |
Sponsors and Collaborators
R3 Stem Cell
Investigators
| Study Chair: | Dr. Ayn O'Reilly, PhD | Solutions IRB |
Additional Information:
| Responsible Party: | R3 Stem Cell |
| ClinicalTrials.gov Identifier: | NCT03899298 History of Changes |
| Other Study ID Numbers: |
#2018/10/11 |
| First Posted: | April 2, 2019 Key Record Dates |
| Last Update Posted: | April 2, 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| 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:
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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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Disease Lung Diseases Alzheimer Disease Kidney Diseases Cardiomyopathies Renal Insufficiency Erectile Dysfunction Autoimmune Diseases Urologic Diseases Musculoskeletal Diseases Nervous System Diseases Peripheral Nervous System Diseases Pathologic Processes Respiratory Tract Diseases |
Dementia Brain Diseases Central Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Heart Diseases Cardiovascular Diseases Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Immune System Diseases Neuromuscular Diseases |