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Stem Cell Therapy

MultiStem for Stem Cells

Phase 2

Recruiting

Led By Charles Cox, MD

Research Sponsored by Athersys, Inc

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

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

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 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

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

866 Previous Clinical Trials

327,151 Total Patients Enrolled

Memorial Hermann HospitalOTHER

16 Previous Clinical Trials

56,119 Total Patients Enrolled

Athersys, IncLead Sponsor

10 Previous Clinical Trials

1,073 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this research project?

"Affirmative. The clinicaltrials.gov data confirms that this medical experiment, which was initially launched on November 9th 2020, is currently in search of participants. Around 156 test subjects are required from a single research centre."

Answered by AI

How innovative is this clinical trial?

"As of now, four research projects centered on MultiStem are currently being conducted in 22 cities across three countries. Originally launched by Healios K.K. back in 2017, the Phase 2 & 3 trial involved 220 participants and has since been followed up with 18324 studies over the past several years."

Answered by AI

Is enrollment still open for this investigation?

"Affirmative. The information on clinicaltrials.gov states that the trial is currently enrolling participants, first posted on November 9th 2020 and last updated February 14 2022. This study necessitates 156 patients to be recruited from a single medical centre."

Answered by AI

Has the FDA sanctioned MultiStem for therapeutic use?

"MultiStem has yet to demonstrate efficacy in clinical trials, so it received a rating of 2 on the safety scale."

Answered by AI

Are there any other investigations that have utilized MultiStem technology?

"Currently, 4 clinical trials are actively studying the efficacy of MultiStem with 3 in Phase 3. These studies can be found at 32 centres across the United States, most notably Houston, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome

2020. "MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04533464.