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

Phase 1

Not yet recruiting

• Conditions: Erectile Dysfunction; Renal Insufficiency; Kidney Diseases; Cardiomyopathies; CHF; Renal Failure; Cardiac Event; Arthritis; Neurologic Disorder; Urologic Diseases
• Interventions: Biological: Amniotic and Umbilical Cord Tissue Procedure

• Registration Number: NCT03899298
• Lead Sponsor: R3 Stem Cell

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.

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:

1. Orthopedic Condition = Injection

2. 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.

3. Urologic = Injection

4. Autoimmune = IV Infusion

5. Cardiac = IV Infusion

6. Pulmonary = IV Infusion plus Nebulizer

7. 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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-02
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22
• Study Start: 2019-09-01
• Primary Completion: 2024-03-20
• Study Completion: 2029-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Age 18 and over.
2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms.
3. Competent to understand the study protocol and provide voluntary informed consent.
4. 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

1. Active Cancer
2. Pregnancy, Lactating
3. Severe Clotting disorder
4. Myocardial Infarction less than six months ago.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amniotic and Umbilical Cord Tissue for Orthopedic Conditions	Amniotic and Umbilical Cord Tissue Procedure	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.
Amniotic and Umbilical Cord Tissue for Neurologic Conditions	Amniotic and Umbilical Cord Tissue Procedure	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.
Amniotic and Umbilical Cord Tissue for Urologic Conditions	Amniotic and Umbilical Cord Tissue Procedure	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.
Amniotic and Umbilical Cord Tissue for Cardiac Conditions	Amniotic and Umbilical Cord Tissue Procedure	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.
Amniotic and Umbilical Cord Tissue for Autoimmune Conditions	Amniotic and Umbilical Cord Tissue Procedure	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.
Amniotic and Umbilical Cord Tissue for Renal Conditions	Amniotic and Umbilical Cord Tissue Procedure	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.
Amniotic and Umbilical Cord Tissue for Pulmonary Conditions	Amniotic and Umbilical Cord Tissue Procedure	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.

Primary Outcome Measures

Name	Time	Method
Disabilities of Arm, Shoulder, Hand Questionnaire (DASH)	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)	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)	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.
Clinical Chronic Obstructive Pulmonary Disease Questionnaire	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.
Assessment of Quality of Life Questionnaire (AQOL)	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.
Mini Mental State Examination (MMSE)	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	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	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)	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).