Clinical trial NCT04684602: Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions
Official title: Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Autoimmune Diseases
Cardiovascular Disorders
Diabetes Complications
Integumentary Disease
Musculoskeletal Disorders
Neurodegenerative Disorders
Neurologic Disorders
Pulmonary Disorders
Sexual Dysfunction
Urologic Disorders
Viral Illness
Keywords: stem cell therapy
umbilical cord stem cells
amniotic stem cells
stem cells
MSC
Mesenchymal Stem Cell
Medicinal Signaling Cell
Erectile Dysfunction
Heart Diseases
Mental Disorders
Neurocognitive Disorders
Neurodegenerative Diseases
Central Nervous System Diseases
Tauopathies
Brain Diseases
Dementia
Disease
Cardiomyopathies
Urologic Diseases
Peripheral Nervous System Diseases
Nervous System Diseases
Alzheimer Disease
Musculoskeletal Diseases
Cardiovascular Diseases
Immune System Diseases
Neuromuscular Diseases
Covid-19
Lead sponsor: Thomas Advanced Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: HeartStem Institute
name: NuStem
First posted: 2020-12-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
measure: Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
measure: Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
measure: Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
measure: Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
measure: Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
measure: Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
measure: Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.
timeFrame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites
state: California
Study officials:
affiliation: HeartStem Institute, Southern California Hospital at Culver City
name: Ernst R Von Schwarz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: