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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684602
• Other study ID #: ICSS-2020-032
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 9, 2020
• Est. completion date: December 9, 2030

Study information

• Verified date: April 2022
• Source: Thomas Advanced Medical LLC
• Contact: Paul C Bogaardt, PhD(c), MSc, MBA
• Phone: 866 864 7789
• Email: paul[@]thomasadvancedmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 9, 2030
• Est. primary completion date: July 9, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Cardiovascular Diseases
• Cardiovascular Disorders
• Diabetes Complications
• Disease
• Integumentary Disease
• Lung Diseases
• Musculoskeletal Diseases
• Musculoskeletal Disorders
• Nervous System Diseases
• Neurodegenerative Diseases
• Neurodegenerative Disorders
• Neurologic Disorders
• Pulmonary Disorders
• Sexual Dysfunction
• Skin Diseases
• Urologic Disorders
• Viral Illness

Intervention

Biological:
• PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.

Locations

Country	Name	City	State
United States	Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites	Culver City	California

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Advanced Medical LLC	HeartStem Institute, NuStem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 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.	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Primary	Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.	Upper Extremity Outcome Instrument	Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Primary	Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.	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 6 months and 12 months.
Primary	Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.	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 6 months and 12 months.
Primary	Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.	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 6 months and 12 months.
Primary	Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.	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 6 months and 12 months.
Primary	Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.	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 6 months and 12 months.
Primary	Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.	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 6 months and 12 months.