Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions

Sponsor

Thomas Advanced Medical LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04684602

Collaborator

HeartStem Institute (Other), NuStem (Other)

5,000

Enrollment

Location

Arms

125

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diseases Cardiovascular Disorders Diabetes Complications Integumentary Disease Musculoskeletal Disorders Neurodegenerative Disorders Neurologic Disorders Pulmonary Disorders Sexual Dysfunction Urologic Disorders Viral Illness	Biological: PrimePro™/ PrimeMSK™	Phase 1/Phase 2

Detailed Description

This study investigates clinical outcomes of treatments for numerous indications including:

Autoimmune, Cardiovascular, Diabetes, Integumentary, Neurologic / Neurodegenerative, Pulmonary, Orthopedic Diseases, Sexual Dysfunction, Urologic Disorders and Viral Illnesses.

Our hypotheses posit that regenerative treatments are both safe and statistically beneficial for a range of conditions. Outcomes will be determined by multiple valid outcome instruments that measure general quality of life information along with condition-specific information.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a multi-center, prospective, open label clinical trial. It will include 5000 patients suffering acute and chronic conditions under 10 different categories. Patients will undergo a single treatment with a biological tissue allograft and will be followed for 12 months.This is a multi-center, prospective, open label clinical trial. It will include 5000 patients suffering acute and chronic conditions under 10 different categories. Patients will undergo a single treatment with a biological tissue allograft and will be followed for 12 months.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions

Actual Study Start Date :

Jul 9, 2020

Anticipated Primary Completion Date :

Jul 9, 2030

Anticipated Study Completion Date :

Dec 9, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Autoimmune Diseases Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for autoimmune conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 2: Cardiovascular Disorders Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for cardiovascular disorders and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 3: Diabetes Complications Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for diabetes complications. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 4: Integumentary Disease Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for integumentary diseases and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 5: Musculoskeletal Disorders Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for orthopedic and musculoskeletal conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 6: Neurodegenerative Disorders Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for neurologic and neurodegenerative disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 7: Pulmonary Disorders Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for pulmonary disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 8: Sexual Dysfunction Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for sexual dysfunction conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 9: Urologic Disorders Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for urologic conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.
Experimental: Arm 10: Viral Illnesses Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for viral illnesses. Outcomes will be compared to results in peer-reviewed literature for several conditions.	Biological: PrimePro™/ PrimeMSK™ Injection via condition specific route of administration.

Outcome Measures

Primary Outcome Measures

Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
General Health Outcome Instrument used to derive a simple psychometric score for health related quality of life which provides scores on various dimensions or items describing the systems. The score is derived by adding the unweighted response order of each question, with a lower score denoting a better quality of life.
Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
Upper Extremity Outcome Instrument
Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.
Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months. [Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18 and older
Ability to provide informed consent
Availability for follow up visits

Exclusion Criteria:

Active or recent malignancy (within last 2 years)
Pregnancy or breast-feeding
Inability to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites	Culver City	California	United States	92032