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

NCT ID: NCT05018819

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2027-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Single intravenous infusion of 100 million cells

Group Type EXPERIMENTAL

AlloRx

Intervention Type BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Foundation for Orthopaedics and Regenerative Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chadwick Prodromos, MD

Role: PRINCIPAL_INVESTIGATOR

The Foundation for Orthopaedics and Regenerative Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Surgical Associates Center

St John's, , Antigua and Barbuda

Site Status RECRUITING

Athens Beverly Hills Medical Group

Glyfada, Athens, Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Antigua and Barbuda Greece

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chadwick Prodromos, M.D.

Role: primary

8476996810

Chadwick Prodromos, M.D.

Role: primary

8476996810

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23802141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23139425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29637820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23281216 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SC-11-ATG-11-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NS-050/NCNP-03 in Boys With DMD (Meteor50)
NCT06053814 RECRUITING PHASE1/PHASE2
Mesenchymal Stem Cell Therapy in Multiple System Atrophy
NCT02315027 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Mexiletine and Non Dystrophic Myotonias
NCT02336477 COMPLETED PHASE3