What side effects are associated with this type of intervention?

Common treatments involving stem cells, such as hematopoietic stem cell transplantation (HSCT), can have side effects including graft-versus-host disease (GVHD), infections, and organ damage. For treatments similar to Tranexamic Acid, which is used to reduce bleeding, side effects may include nausea, vomiting, diarrhea, and an increased risk of thrombosis. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks of the treatment.

What prior FDA approvals exist?

The FDA has approved various treatments involving stem cells, particularly for hematologic conditions. While Tranexamic Acid is an antifibrinolytic agent used to reduce blood loss during surgeries like total knee arthroplasty, it is not directly related to stem cell treatments. However, thrombopoietic agents like romiplostim and eltrombopag have been approved for conditions involving thrombocytopenia, which can be relevant in the context of stem cell therapies for hematologic disorders. These agents help stimulate platelet production, which can be crucial for patients undergoing treatments that affect bone marrow and blood cell counts.

What other types of research exist?

Promising novel alternatives to Tranexamic Acid for stem cell patients include thrombopoietic growth factors like eltrombopag, which promotes platelet production, and gene therapy approaches such as anti-TFPI antibodies (e.g., concizumab) that enhance coagulation. These therapies aim to manage bleeding risks effectively in patients undergoing stem cell treatments.

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Stem Cell Therapy

MultiStem for Trauma-Induced Multiple Organ Failure

Phase 2

Recruiting

Led By Charles Cox, MD

Research Sponsored by Healios K.K.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30, day 90, day 365

Summary

This trial is testing a new treatment for severely injured trauma patients who have just been hospitalized and survived initial resuscitation. The study aims to find better ways to help these critically injured patients recover.

Who is the study for?

This trial is for adults over 18 who've had severe trauma, received blood products, and are stable enough to survive at least 24 hours post-injury. They must start treatment within a day of injury. Excluded are pregnant women, prisoners, those with certain kidney or immune conditions, large burns or non-survivable head injuries.

What is being tested?

The study tests MultiStem®, a stem cell therapy against a placebo in severely injured patients to see if it can prevent organ failure after trauma. It's randomized and double-blind meaning neither doctors nor patients know who gets the real treatment.

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to intravenous treatments such as discomfort at the infusion site or allergic reactions due to components like dimethyl sulfoxide or human serum albumin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30, day 90, day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30, day 90, day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30, day 90, day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Hospital days

ICU days

Mortality

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MultiStemExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MultiStem

2016

Completed Phase 2

~170

Do I qualify?Apply below to find out

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 stem cells include the use of mesenchymal stem cells (MSCs) and hematopoietic stem cells (HSCs). MSCs are multipotent cells that can differentiate into various cell types, aiding in tissue repair and reducing inflammation. HSCs are primarily used in hematopoietic cell transplantation to restore bone marrow function in patients with hematologic malignancies. These treatments are crucial for stem cell patients as they offer potential for regeneration and repair of damaged tissues, improving outcomes in conditions like leukemia and other blood disorders. While Tranexamic Acid is an antifibrinolytic agent used to reduce bleeding, it is not directly related to stem cell treatments but highlights the importance of supportive care in managing complications during stem cell therapy.

Cluster-Like Headache Revealing Polycythemia Vera: A Case Report.Only minor stem cell mobilization in head and neck irradiated patients treated with hyperbaric oxygen.