Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP

NCT03979898 | Completed Early Phase 1 DMC

• 1 other identifier: biostar-CP
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Kaufman Assessment Battery for Children (K-ABC)

  Change from Baseline K-ABC at 12 months

  Baseline and 12 month

Secondary Outcomes (7)

• Blood concentration test

  Baseline, 1, 3, 6 and 12 month

• Gross Motor Function Measurement (GMFM)

  Baseline, 3, 6 and 12 month

• Box and Block Test

  Baseline, 3, 6 and 12 month

• Modified Ashworth Scale (MAS)

  Baseline, 3, 6 and 12 month

• SF-36

  Baseline, 3, 6 and 12 month

Study Arms (1)

Astrostem

EXPERIMENTAL

Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Biological: ASTROSTEM

Interventions

ASTROSTEM BIOLOGICAL

Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10\^7cells/5mL 15kg \~ 25kg : 1x10\^8cells/10mL 25kg over : 1.5x10\^8cells/15mL

Also known as: Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Astrostem

Eligibility Criteria

• Age: 36 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth
• Age : 36 months - 12 year, males and females
• Subjects who understand and sign the consent form for this study
• Kaufman Assessment Battery for Children 50\<K-ABC\<100

You may not qualify if:

• The last three months had seizures or epilepsy patients taking the durg
• Genetic Diseases
• Recent cancer patients within 1 year
• patients witn a psychiatric disorder that may interfere in the clinical trial
• participating another clinical trials within 3 months
• Recently there is a change of the abrupt symptoms within three months of the patient
• Subjects with a infectious disease include HIV and VDRL
• Patients who penicillin hypersensitivity reactions
• Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Sponsors & Collaborators

• R-Bio: lead
• Kyung Hee University Hospital at Gangdong: collaborator

Study Sites (1)

KyungHee University Gandong Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: June 7, 2019
• Study Start: June 15, 2017
• Primary Completion: April 23, 2019
• Study Completion: May 13, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)