Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intravenous Infusion for CP

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase: Suspended; Phase 1

Conditions: Cerebral Palsy

Treatments: Biological: autologous adipose derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05018871

SC-8-GR-8-04

Details and patient eligibility

About

This trial will study the safety and efficacy of intravenous infusion of cultured autologous adult adipose derived mesenchymal stem cells for the treatment of Cerebral Palsy

Full 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 autologous adult adipose derived mesenchymal stem cells (AD-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of AD-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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Treatment Group

Experimental group

Description:

Single intravenous infusion of 100 million cells

Treatment:

Biological: autologous adipose derived mesenchymal stem cells