Fetal derived stem cells for Parkinson’s disease
| ISRCTN | ISRCTN39104513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39104513 |
| Secondary identifying numbers | CMN2012-027 |
- Submission date
- 23/04/2016
- Registration date
- 04/05/2016
- Last edited
- 08/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Camino a Santa Teresa 1055-474
Mexico City
10700
Mexico
 ORCID ID |
0000-0002-1181-3029 |
|---|---|
| Phone | 52555684319 |
| imadrazon@parkinsonmx.com |
Study information
| Study design | Longitudinal, prospective, interventional, uncontrolled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 18/02/2011 |
| Completion date | 25/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 8 |
| Total final enrolment | 8 |
| Key inclusion criteria | Healthy patient with Parkinson's Disease |
| Key exclusion criteria | 1. Pregnancy 2. Secondary pathology |
| Date of first enrolment | 01/06/2011 |
| Date of final enrolment | 14/11/2012 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Mexico City
10700
Mexico
Sponsor information
Industry
2360 Eastman Ave Ste 101
Oxnard, California
93030
United States of America
"ROR" |
https://ror.org/059xdv132 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | We intend to share participant level data in Dryad, however the details are still being decided. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 01/10/2018 | 01/10/2018 | No | No | |
| Basic results | 04/10/2018 | 04/10/2018 | No | No | |
| Results article | results | 01/03/2019 | 08/08/2019 | Yes | No |
Additional files
- ISRCTN39104513_BasicResults_1Oct18.pdf
- Uploaded 01/10/2018
- ISRCTN39104513_BasicResults_version 2_4Oct18.pdf
- Uploaded 04/10/2018
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
