Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Prof Ignacio Madrazo


Contact details

Camino a Santa Teresa 1055-474
Mexico City

Additional identifiers

EudraCT number number

Protocol/serial number


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.


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Parkinson's Disease


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



Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Healthy patient with Parkinson's Disease

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Pregnancy
2. Secondary pathology

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Angeles Pedregal Hospital
Camino a Santa Teresa 1055
Mexico City

Sponsor information


Celavie Biosciences

Sponsor details

2360 Eastman Ave Ste 101
United States of America

Sponsor type




Funder type


Funder name

Celavie Biosciences

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: we intend to share participant level data in Dryad, however the details are still being decided.

Intention to publish date


Participant level data

Stored in repository

Basic results (scientific)

See additional files (ISRCTN39104513_BasicResults_1Oct18.pdf and

Publication list

2019 results in: (added 08/08/2019)

Publication citations

Editorial Notes

08/08/2019: Publication reference and total final enrolment added. 04/10/2018: The following changes were made to the trial record: 1. Version 2 of the basic results summary of this trial have been uploaded as an additional file. 2. The publication and dissemination plan was added. 3. The intention to publish date was updated from 15/05/2016 to 31/12/2018. 4. The participant level data was updated. 01/10/2018: The basic results of this trial have been uploaded as an additional file. 05/05/2016: Internal review