What side effects are associated with this type of intervention?

Common treatments for diabetes include insulin therapy, oral hypoglycemic agents, and newer classes like GLP-1 receptor agonists and SGLT2 inhibitors. Insulin therapy can cause hypoglycemia and weight gain. Oral agents like metformin may lead to gastrointestinal issues such as nausea and diarrhea. GLP-1 receptor agonists, such as exenatide and liraglutide, can cause nausea, vomiting, and potential risks of pancreatitis. SGLT2 inhibitors may increase the risk of urinary tract infections and genital infections. Regenerative treatments like stem cell therapy are still under investigation, but early findings suggest they are generally safe and well-tolerated, though long-term data is needed to fully understand their side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetes, including GLP-1 agonists like liraglutide and extended-release exenatide, which are used to improve glycemic control in pediatric patients with type 2 diabetes. These treatments, while not stem cell therapies, represent advanced pharmacologic interventions aimed at managing diabetes. Additionally, there are ongoing studies and trials exploring the use of stem cell therapy for various conditions, including diabetes, although these are not yet widely approved for clinical use.

What other types of research exist?

Promising novel alternatives to stem cell therapy for diabetes patients include: 1) Glucagon-like peptide-1 receptor agonists (GLP1-RAs), which have shown efficacy in improving glycemic control and cardiovascular outcomes. 2) Sodium-glucose co-transporter 2 inhibitors (SGLT2-i), which have demonstrated reductions in cardiovascular events and improved safety profiles. 3) Continuous glucose monitoring (CGM) systems, which enhance glucose management in patients on multiple daily insulin injections. 4) Bariatric surgery, which has shown long-term benefits in reversing type 2 diabetes and improving cardiovascular risk factors in severely obese adolescents.

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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

No Placebo-Only Group

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 below

Select...

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 1Eligibility criteria met

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.