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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CP

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AlloRx
Sponsored by
The Foundation for Orthopaedics and Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, CP, stem cell treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Cerebral Palsy

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
  • Center for Investigation in Tissue Engineering and Cellular TherapyRecruiting
  • Medyca BosquesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Single 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: Gross Motor Function Measure (GMFM)
It will be completed for each follow up point

Full Information

First Posted
August 19, 2021
Last Updated
October 25, 2022
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05018819
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CP
Official Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (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
Data Monitoring Committee
No

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 Cerebral Palsy
Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of UC-MSCs. The total dose 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
Cerebral Palsy
Keywords
Cerebral Palsy, CP, 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
Single 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: Gross Motor Function Measure (GMFM)
Description
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 Cerebral Palsy 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
Center for Investigation in Tissue Engineering and Cellular Therapy
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, M.D.
Phone
8476996810
Ext
202
Email
Care@thepsci.com
Facility Name
Medyca Bosques
City
San Pedro Garza García
State/Province
N.L
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, M.D.
Phone
8476996810
Ext
202
Email
Care@thepsci.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23802141
Citation
Alotaibi M, Long T, Kennedy E, Bavishi S. The efficacy of GMFM-88 and GMFM-66 to detect changes in gross motor function in children with cerebral palsy (CP): a literature review. Disabil Rehabil. 2014;36(8):617-27. doi: 10.3109/09638288.2013.805820. Epub 2013 Jun 26.
Results Reference
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PubMed Identifier
23139425
Citation
Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8.
Results Reference
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PubMed Identifier
29637820
Citation
Huang L, Zhang C, Gu J, Wu W, Shen Z, Zhou X, Lu H. A Randomized, Placebo-Controlled Trial of Human Umbilical Cord Blood Mesenchymal Stem Cell Infusion for Children With Cerebral Palsy. Cell Transplant. 2018 Feb;27(2):325-334. doi: 10.1177/0963689717729379.
Results Reference
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PubMed Identifier
23281216
Citation
Min K, Song J, Kang JY, Ko J, Ryu JS, Kang MS, Jang SJ, Kim SH, Oh D, Kim MK, Kim SS, Kim M. Umbilical cord blood therapy potentiated with erythropoietin for children with cerebral palsy: a double-blind, randomized, placebo-controlled trial. Stem Cells. 2013 Mar;31(3):581-91. doi: 10.1002/stem.1304.
Results Reference
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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CP

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