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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amniotic and Umbilical Cord Tissue for Autoimmune Conditions | Experimental | 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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| Amniotic and Umbilical Cord Tissue for Orthopedic Conditions | Experimental | 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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| Amniotic and Umbilical Cord Tissue for Neurologic Conditions | Experimental | 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. |
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| Amniotic and Umbilical Cord Tissue for Urologic Conditions | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of Arm, Shoulder, Hand Questionnaire (DASH) | Upper Extremity Outcome Instrument | 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. |
| Sexual Health Inventory for Men Questionnaire (SHIM) | Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction. | 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. |
| Kidney Disease and Quality of Life Questionnaire (KDQOL) | 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. | 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. |
| Assessment of Quality of Life Questionnaire (AQOL) | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David L Greene, MD, MBA | Contact | (844) 438-7836 | info@r3stemcell.com |
| Name | Affiliation | Role |
|---|---|---|
| David Greene, MD, MBA | R3 Stem Cell | Study Director |
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| Label | URL |
|---|---|
| R3 Stem Cell | View source |
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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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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.
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No masking.
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| Amniotic and Umbilical Cord Tissue for Cardiac Conditions | Experimental | 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. |
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| Amniotic and Umbilical Cord Tissue for Renal Conditions | Experimental | 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. |
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| Amniotic and Umbilical Cord Tissue for Pulmonary Conditions | Experimental | 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. |
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| Clinical Chronic Obstructive Pulmonary Disease Questionnaire | COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status. | 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. |
| Mini Mental State Examination (MMSE) | Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia. | 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. |
| O'Leary/Sant Questionnaire | Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function. | 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. |
| Oswestry Low Back Pain Disability Questionnaire | Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function. | 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. |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) | Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). | 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. |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009422 | Nervous System Diseases |
| D014570 | Urologic Diseases |
| D007172 | Erectile Dysfunction |
| D001327 | Autoimmune Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000544 | Alzheimer Disease |
| D020521 | Stroke |
| D009443 | Neuritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D007154 | Immune System Diseases |
| D006331 | Heart Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D007592 | Joint Diseases |
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