Condition category
Nervous System Diseases
Date applied
23/04/2016
Date assigned
04/05/2016
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parkinson’s disease (PD) is a chronic condition where nerve cells in a small part of the brain called the substantia nigra become damaged and die. The nerve cells in this region send signals that controls the muscles of the body. Dopamine is the main neurotransmitter produced by these nerve cells. As more of these cells die, the amount of dopamine produced also falls. Over time, the lack of nerve cells and low levels of dopamine affects how well the person affected can control their muscles. The most common symptoms of the condition are slowness of movement, muscle stiffness and shaking (tremors). Although temporarily effective, current treatments fail to control symptoms and stop the disease progressing. The aim of this study was to test the safety and possible benefits of a novel strategy based on grafting human fetal brain stem cells (hfSCs) I the hope that they help address both dopamine and non-dopamine aspects of the disease.

Who can participate?
Patients with moderate to severe Parkinson’s disease.

What does the study involve?
Participants are first temporarily immunosuppressed with the drug cyclosporine. This is to make sure that they don’t reject the stem cells. The cells are then injected into a part of the brain called the dorsal putamina. All participants are then followed up for a year to see if any side effects or complications arise and whether their symptoms improve.

What are the possible benefits and risks of participating?
Benefits may include an improvement in PD symptoms. Potential risks include bleeding in the brain, brain swelling and immune rejection of the cells.

Where is the study run from?
Angeles Pedregal Hospital (Mexico)

When is the study starting and how long is it expected to run for?
February 2011 to August 2018

Who is funding the study?
Celavie Biosciences

Who is the main contact?
Professor Ignacio Madrazo
imadrazon@parkinsonmx.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ignacio Madrazo

ORCID ID

http://orcid.org/0000-0002-1181-3029

Contact details

Camino a Santa Teresa 1055-474
Mexico City
10700
Mexico
52555684319
imadrazon@parkinsonmx.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CMN2012-027

Study information

Scientific title

Undifferentiated human fetal brain-derived stem cells grafted into putamina of parkinsonian patients is safe and moderately effective: a phase I clinical trial.

Acronym

Study hypothesis

If undifferentiated human fetal brain-derived stem cells (hfSC) are transplanted in the putamina, then patients will Parkinson's Disease will not suffer harm and will decrease their disease.

Ethics approval

1. Federal Commission for Prevention of Sanitary Risks (Comisión Federal para la Prevensión de Riesgos Sanitarios), 12/02/2014, ref: CMN2012-027
2. Research Committee and Research Ethics Operadora Hospital (Comité de de Investigación y Ética en Investigación de Operadora de Hospitales Ángeles S.A. de C.V), 01/08/2014

Study design

Longitudinal, prospective, interventional, uncontrolled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Parkinson's Disease

Intervention

Stereotactical transplant of stem cells into both putamina. One million million stem cells were deposited in two areas (anterior and posterior) of both putamina. All of this is by one trephine in the coronal suture.

The patients were protected 24 hours before surgery with IV antibiotics, and a day before started with cyclosporine and indometacine which lasted for one month in the first drug and two months in the second. After surgery, they were transferred to the ICU for 24 hours and finally after a post-op MRI control, sent home.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Safety of transplantation of cells, measured by recording side effects or complications arising after surgery.
2. Degree of motor improvement, measured using the unified Parkinson's disease rating scale (UPDRS) score

Secondary outcome measures

1. Cognitive performance, measured using the mini–mental state examination (MMSE) score at baseline and at 1 year follow-up
2. Uptake patterns of DTBZ, FDOPA and RAC

Overall trial start date

18/02/2011

Overall trial end date

25/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy patient with Parkinson's Disease

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. Pregnancy
2. Secondary pathology

Recruitment start date

01/06/2011

Recruitment end date

14/11/2012

Locations

Countries of recruitment

Mexico

Trial participating centre

Angeles Pedregal Hospital
Camino a Santa Teresa 1055
Mexico City
10700
Mexico

Sponsor information

Organisation

Celavie Biosciences

Sponsor details

2360 Eastman Ave Ste 101
Oxnard
California
93030
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Celavie Biosciences

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

15/05/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/05/2016: Internal review