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Stem Cell Therapy
Stem Cell Therapy for Chronic and Acute Conditions
Phase 1 & 2
Recruiting
Led By Ernst R Von Schwarz, MD, PhD
Research Sponsored by Thomas Advanced Medical LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Awards & highlights
Summary
This trial is testing stem cell therapy, which uses special cells to repair or replace damaged tissues. It targets patients with a range of acute and chronic conditions that may not respond well to traditional treatments. The therapy works by transforming stem cells into the needed cell types to improve organ and tissue function.
Who is the study for?
This trial is for adults over 18 who can attend follow-up visits and give informed consent. It's not suitable for those with recent cancer history (within the last 2 years), pregnant or breastfeeding individuals, or anyone unable to consent.
What is being tested?
The study tests stem cell therapies called PrimePro™/PrimeMSK™ on a range of conditions including musculoskeletal, neurological, skin diseases, cardiovascular issues, diabetes, neurodegenerative and lung diseases, autoimmune disorders, sexual dysfunction and viral infections.
What are the potential side effects?
While specific side effects are not listed here, stem cell therapy may include risks such as infection at injection site, immune reactions to the cells used in treatment or failure of the cells to work as expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.
Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.
Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.
+5 moreTrial Design
10Treatment groups
Experimental Treatment
Group I: Arm 9: Urologic DisordersExperimental Treatment1 Intervention
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.
Group II: Arm 8: Sexual DysfunctionExperimental Treatment1 Intervention
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.
Group III: Arm 7: Pulmonary DisordersExperimental Treatment1 Intervention
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.
Group IV: Arm 6: Neurodegenerative DisordersExperimental Treatment1 Intervention
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.
Group V: Arm 5: Musculoskeletal DisordersExperimental Treatment1 Intervention
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.
Group VI: Arm 4: Integumentary DiseaseExperimental Treatment1 Intervention
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.
Group VII: Arm 3: Diabetes ComplicationsExperimental Treatment1 Intervention
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.
Group VIII: Arm 2: Cardiovascular DisordersExperimental Treatment1 Intervention
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.
Group IX: Arm 1: Autoimmune DiseasesExperimental Treatment1 Intervention
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.
Group X: Arm 10: Viral IllnessesExperimental Treatment1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for diabetes include insulin therapy, GLP-1 receptor agonists, and SGLT2 inhibitors. Insulin therapy involves administering exogenous insulin to help regulate blood glucose levels, which is crucial for patients whose bodies do not produce enough insulin.
GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, thereby improving blood glucose control and offering cardiovascular benefits. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in urine and improved glycemic control.
These treatments are essential for managing blood glucose levels and preventing complications. Regenerative treatments like stem cell therapy aim to restore the body's ability to produce insulin by regenerating or replacing damaged pancreatic cells, offering a potential long-term solution for diabetes management.
Exogenous insulin administration and cardiovascular risk in non-insulin-dependent and insulin-dependent diabetes mellitus.Glucose-lowering treatment and clinical results in 163 121 patients with type 2 diabetes: an observational study from the Swedish national diabetes register.
Exogenous insulin administration and cardiovascular risk in non-insulin-dependent and insulin-dependent diabetes mellitus.Glucose-lowering treatment and clinical results in 163 121 patients with type 2 diabetes: an observational study from the Swedish national diabetes register.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Thomas Advanced Medical LLCLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
HeartStem InstituteUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
NuStemUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer in the last 2 years.I can attend all required follow-up visits.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 4: Integumentary Disease
- Group 2: Arm 5: Musculoskeletal Disorders
- Group 3: Arm 7: Pulmonary Disorders
- Group 4: Arm 8: Sexual Dysfunction
- Group 5: Arm 9: Urologic Disorders
- Group 6: Arm 10: Viral Illnesses
- Group 7: Arm 1: Autoimmune Diseases
- Group 8: Arm 2: Cardiovascular Disorders
- Group 9: Arm 3: Diabetes Complications
- Group 10: Arm 6: Neurodegenerative Disorders
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lung Disease Patient Testimony for trial: Trial Name: NCT04684602 — Phase 1 & 2
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