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Stem Cell Therapy
MultiStem for Stem Cells
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
Awards & highlights
Study Summary
This trial looks at whether a certain drug can help severely injured patients who have just been resuscitated.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A composite of the highest Acute Kidney Injury stage (based on KDIGO guidelines)
Secondary outcome measures
Hospital days
ICU days
Kidney
+3 moreTrial 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
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.
Cluster-Like Headache Revealing Polycythemia Vera: A Case Report.Only minor stem cell mobilization in head and neck irradiated patients treated with hyperbaric oxygen.
Find a Location
Who is running the clinical trial?
Healios K.K.Lead Sponsor
12 Previous Clinical Trials
1,314 Total Patients Enrolled
United States Department of DefenseFED
870 Previous Clinical Trials
327,564 Total Patients Enrolled
Memorial Hermann HospitalOTHER
16 Previous Clinical Trials
56,119 Total Patients Enrolled
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