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

R3 Stem Cell

Status and phase: Not yet enrolling; Phase 1

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

Treatments: Biological: Amniotic and Umbilical Cord Tissue Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03899298

#2018/10/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,000 participants in 7 patient groups

Amniotic and Umbilical Cord Tissue for Autoimmune Conditions

Experimental group

Description:

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.

Treatment:

Biological: Amniotic and Umbilical Cord Tissue Procedure

Amniotic and Umbilical Cord Tissue for Orthopedic Conditions

Experimental group

Description:

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.

Treatment:

Biological: Amniotic and Umbilical Cord Tissue Procedure

Amniotic and Umbilical Cord Tissue for Neurologic Conditions

Experimental group

Description:

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.

Treatment:

Biological: Amniotic and Umbilical Cord Tissue Procedure

Amniotic and Umbilical Cord Tissue for Urologic Conditions

Experimental group

Description:

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.

Treatment:

Biological: Amniotic and Umbilical Cord Tissue Procedure

Amniotic and Umbilical Cord Tissue for Cardiac Conditions

Experimental group

Description:

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.

Treatment:

Biological: Amniotic and Umbilical Cord Tissue Procedure

Amniotic and Umbilical Cord Tissue for Renal Conditions

Experimental group

Description:

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.

Treatment:

Biological: Amniotic and Umbilical Cord Tissue Procedure

Amniotic and Umbilical Cord Tissue for Pulmonary Conditions

Experimental group

Description:

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.

Treatment:

Biological: Amniotic and Umbilical Cord Tissue Procedure