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Stem Cell Therapy

Stem Cell Therapy for Post-Concussion Syndrome

Phase 1

Waitlist Available

Led By Peter B Hanson, MD

Research Sponsored by American CryoStem Corporation

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 baseline, 1 month and 6 months post treatment

Awards & highlights

Study Summary

This trialtests a treatment for Post Concussion Syndrome that may reduce symptoms and provide safety/tolerability data.

Who is the study for?

Adults aged 18-65 with a confirmed diagnosis of Post-Concussion Syndrome, meeting specific symptom criteria. Participants must be able to follow the study plan and use two effective contraception methods if applicable. Excluded are those with certain heart conditions, high blood pressure, recent strokes or DVTs, immunosuppressive therapy within 3 months, drug abuse history within 2 years, active infections or cancer.Check my eligibility

What is being tested?

The trial is testing the safety and symptom relief of intravenous infusions of adipose-derived stem cells at different doses (50, 150, and 300 units) compared to a placebo in treating Post-Concussion Syndrome. This Phase 1 trial aims to determine tolerability and initial effectiveness.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood pressure or immune response due to stem cell infusion. Specific side effects will be monitored as this is a preliminary safety study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month and 6 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month and 6 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month and 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of Attention and Executive functions

Assessment of Contextual Verbal Learning

Assessment of Depression by Participant

+9 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: 300 million cell infusionActive Control1 Intervention

Each participant in this arm will receive a single dose of 300 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.

Group II: 50 million cell infusionActive Control1 Intervention

Each participant in this arm will receive a single dose of 50 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.

Group III: 150 million cell infusionActive Control1 Intervention

Each participant in this arm will receive a single dose of 150 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.

Group IV: PlaceboPlacebo Group1 Intervention

Each participant in this arm will receive a single dose of placebo. Upon completion of the study each placebo participant with be given the option to be treated with their cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour. Dosage for the crossover will be determined by the PI following review of data collected from the other arms of the study.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

American CryoStem CorporationLead Sponsor

2 Previous Clinical Trials

22 Total Patients Enrolled

Peter B Hanson, MDPrincipal InvestigatorBiosolutions Clinical Research Center

Media Library

ATCell™ (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04744051 — Phase 1

Frequently Asked Questions

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

What potential risks are associated with a 150 million cell infusion for patients?

"Assessed by our team at Power, the safety of 150 million cell infusion was graded as a 1 due to it being in Phase 1 trials. Therefore, there is only minimal data supporting its efficacy and safety."

Answered by AI

Does this research trial encompass elderly individuals?

"This study is restricted to participants aged 18-65; however, there are separate trials available for underaged patients (390) and seniors (1019)."

Answered by AI

Is there an ongoing call for participants in this clinical experiment?

"The latest updates on clinicaltrials.gov reveal that this medical study is actively looking for volunteers to participate. The trial was originally posted in February 2021, and the information has most recently been modified in mid-February 2022."

Answered by AI

How many participants are presently enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that the trial is currently recruiting individuals, with an initial post on February 1st 2021 and a most recent update on February 14th 2022. The study requires 20 participants to be sourced from one medical centre."

Answered by AI

Is it feasible for me to sign up for this medical experiment?

"This clinical trial is searching for 20 individuals aged 18-65 who have been diagnosed with post-concussion syndrome. To be eligible, applicants must demonstrate the following: Acknowledgement of full understanding and agreement to all protocols outlined in an informed consent document; persisting headaches, dizziness, fatigue or exhaustion; hypersensitivity to light and/or sound; difficulty with memory retention or focus; insomnia symptoms; contraception practices if applicable (hysterectomy/oophorectomy in lieu)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion

2021. "ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04744051.