Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism
Primary Purpose
Autism
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AlloRx
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, stem cell treatment
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Autism
Exclusion Criteria:
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Pregnancy
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
- Medical condition that would (based on the opinion of the investigator) compromise patient's safety
- Previous organ transplant
- Seizure disorder
- Hypersensitivity to sulfur
Sites / Locations
- Medical Surgical Associates CenterRecruiting
- ArtrosRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
One intravenous infusion of 100 million cells
Outcomes
Primary Outcome Measures
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Secondary Outcome Measures
Efficacy: Autism Treatment Evaluation Checklist (ATEC)
ATEC is a questionnaire to measure changes in severity in response to treatment. It will be completed for each follow up point.
Full Information
NCT ID
NCT05003960
First Posted
August 6, 2021
Last Updated
September 20, 2023
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05003960
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism
Official Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2022 (Actual)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Autism
Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Autism. Patients with Autism will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism, stem cell treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
One intravenous infusion of 100 million cells
Intervention Type
Biological
Intervention Name(s)
AlloRx
Intervention Description
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Safety (adverse events)
Description
Clinical monitoring of possible adverse events or complications
Time Frame
Four year follow-up
Secondary Outcome Measure Information:
Title
Efficacy: Autism Treatment Evaluation Checklist (ATEC)
Description
ATEC is a questionnaire to measure changes in severity in response to treatment. It will be completed for each follow up point.
Time Frame
Four year follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Autism
Exclusion Criteria:
Active infection
Active cancer
Chronic multisystem organ failure
Pregnancy
Clinically significant Abnormalities on pre-treatment laboratory evaluation
Medical condition that would (based on the opinion of the investigator) compromise patient's safety
Previous organ transplant
Seizure disorder
Hypersensitivity to sulfur
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, MD
Organizational Affiliation
The Foundation for Orthopaedics and Regenerative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Surgical Associates Center
City
St. John's
Country
Antigua and Barbuda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, M.D.
Phone
8476996810
Email
care@thepsci.com
Facility Name
Artros
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadwick C Prodromos, MD
Phone
8476996810
Email
research@ismoc.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
29462954
Citation
Mahapatra S, Vyshedsky D, Martinez S, Kannel B, Braverman J, Edelson SM, Vyshedskiy A. Autism Treatment Evaluation Checklist (ATEC) Norms: A "Growth Chart" for ATEC Score Changes as a Function of Age. Children (Basel). 2018 Feb 16;5(2):25. doi: 10.3390/children5020025.
Results Reference
background
PubMed Identifier
23978163
Citation
Lv YT, Zhang Y, Liu M, Qiuwaxi JN, Ashwood P, Cho SC, Huan Y, Ge RC, Chen XW, Wang ZJ, Kim BJ, Hu X. Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism. J Transl Med. 2013 Aug 27;11:196. doi: 10.1186/1479-5876-11-196.
Results Reference
background
PubMed Identifier
31187597
Citation
Riordan NH, Hincapie ML, Morales I, Fernandez G, Allen N, Leu C, Madrigal M, Paz Rodriguez J, Novarro N. Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels. Stem Cells Transl Med. 2019 Oct;8(10):1008-1016. doi: 10.1002/sctm.19-0010. Epub 2019 Jun 11.
Results Reference
background
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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism
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