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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03899298
• Other study ID #: #2018/10/11
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2019
• Est. completion date: March 20, 2029

Study information

• Verified date: March 2019
• Source: R3 Stem Cell
• Contact: David L Greene, MD, MBA
• Phone: (844) 438-7836
• Email: info[@]r3stemcell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: March 20, 2029
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Arthritis
• Autoimmune Diseases
• Cardiac Event
• Cardiomyopathies
• CHF
• COPD
• Disease
• Erectile Dysfunction
• Kidney Diseases
• Musculoskeletal Diseases
• Nervous System Diseases
• Neurologic Disorder
• Neuropathy;Peripheral
• Orthopedic Disorder
• Peripheral Nervous System Diseases
• Pulmonary Disease
• Renal Failure
• Renal Insufficiency
• Stroke
• Urologic Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
R3 Stem Cell

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.

External Links

•   R3 Stem Cell