Stem Cell Therapy for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Open Label Study of Autologous Bone Marrow Mononuclear Cells in Cerebral Palsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01978821
• Other study ID #: NGBSI-01
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: October 2018
• Source: Neurogen Brain and Spine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the purpose of this study was to study the effect of stem cell therapy on common symptoms of cerebral palsy patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Months to 22 Years

Eligibility

Inclusion Criteria:

• Diagnosed cases of any type of Cerebral Palsy

• age above 12 months.

Exclusion Criteria:

• presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus

• malignancies

• bleeding tendencies

• pneumonia

• renal failure

• severe liver dysfunction

• severe anemia [Hemoglobin < 8]

• any bone marrow disorder

• space occupying lesion in brain

• other acute medical conditions such as respiratory infection and pyrexia.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Procedure:
• Autologous bone marrow mononuclear cell transplantation

Locations

Country	Name	City	State
India	Neurogen brain and spine institute	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

References & Publications (4)

Alvarez P, Carrillo E, Vélez C, Hita-Contreras F, Martínez-Amat A, Rodríguez-Serrano F, Boulaiz H, Ortiz R, Melguizo C, Prados J, Aránega A. Regulatory systems in bone marrow for hematopoietic stem/progenitor cells mobilization and homing. Biomed Res Int. 2013;2013:312656. doi: 10.1155/2013/312656. Epub 2013 Jun 17. Review. — View Citation

Li Y, Tu L, Chen D, Jiang R, Wang Y, Wang S. [Study on functional recovery of hypoxic-ischemic brain injury by Rg1-induced NSCs]. Zhongguo Zhong Yao Za Zhi. 2012 Feb;37(4):509-14. Chinese. — View Citation

Sharma A, Sane H, Paranjape A, Gokulchandran N, Kulkarni P, Nagrajan A, Badhe P. Positron emission tomography-computer tomography scan used as a monitoring tool following cellular therapy in cerebral palsy and mental retardation-a case report. Case Rep Neurol Med. 2013;2013:141983. doi: 10.1155/2013/141983. Epub 2013 Feb 3. — View Citation

Wang X, Cheng H, Hua R, Yang J, Dai G, Zhang Z, Wang R, Qin C, An Y. Effects of bone marrow mesenchymal stromal cells on gross motor function measure scores of children with cerebral palsy: a preliminary clinical study. Cytotherapy. 2013 Dec;15(12):1549-62. doi: 10.1016/j.jcyt.2013.06.001. Epub 2013 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical symptoms of cerebral palsy after 6 months		Six months