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AzTrials

Parkinson DiseasePhase 3NCT00038116

Embryonic Dopamine Cell Implants for Parkinson's Disease

A Phase 3 study testing embryonic dopamine cell implant surgery in people with Parkinson Disease, run by University of Colorado, Denver at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to determine if patients who received embryonic dopamine cell implant surgery showed significantly greater improvement in their Parkinson's disease than a control group undergoing the placebo treatment, and to determine if the cell implant surgery was more effective in younger or older… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
embryonic dopamine cell implant surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
3 sitesUnited States
Study dates
May 1995to Aug 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic Parkinson's disease of at least 7 years duration and responsive to levodopa. Other Parkinson syndromes excluded.
  • Patients previously tried on other available forms of medical treatment.
  • Age between 20 and 75 years.
  • Presence of an intractable problem, such as "off" periods, dyskinesias, or "freezing," not controlled by dopamine agonists such as levodopa or pergolide.
  • No serious depression and no cognitive impairment.
  • Successful completion of home diary by patient or responsible party.
Show all 11Show fewer
  • Successful videotape recordings at home of "on" and "off" status.
  • Normal MRI of brain within the last 18 months.
  • Fluorodopa PET scan compatible with idiopathic Parkinson's disease.
  • Medically fit to undergo implant surgery with certification by the patient's physician.
  • Able to financially cover expenses not paid for by NIH grant (between $1,000 and $2,000 for unreimbursed travel, video camera, and blood screening as specified in the consent form.

Who cannot join

  • Severe or moderately severe depression or cognitive impairment.
  • Previous brain surgery.
  • Presence of diabetes mellitus, severe cardiopulmonary disease or other severe medical disease, or MRI evidence of cerebrovascular disease.
  • Not medically cleared to undergo a surgical procedure.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University Hospital, the University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • North Shore University Hospital

    Manhasset, New York, 11030

  • The Movement Disorder Center, Columbia-Presbyterian Hospital

    New York, New York, 10032

Other trials in United States

About this study

Official title: Embryonic Dopamine Cell Implants for Parkinson's Disease: A Double-Blind Study

The purpose of this trial is to determine if patients who received embryonic dopamine cell implant surgery showed significantly greater improvement in their Parkinson's disease than a control group undergoing the placebo treatment, and to determine if the cell implant surgery was more effective in younger or older patients.

Read the detailed description

Parkinson's disease is caused by the death of a small number of nerve cells that produce a critical chemical called dopamine. The drug L-dopa can partially make up for the lack of dopamine. As time goes on, however, most patients notice that the drugs do not work as well. Oftentimes, patients develop great fluctuations in motor control. Off drugs they cannot move, and on drugs they have excess, exaggerated movements. Research in animals over the last 20 years has shown that dopamine cells can be replaced by transplants of new cells obtained from fetal brain tissue. For the past 14 years, several laboratories around the world have been performing similar transplants of human fetal brain tissue on patients with Parkinson's disease. So far, it has been impossible to compare results from the different groups because no two centers are performing transplants in the same way.

This study seeks to get around that problem using a controlled clinical trial that compares the embryonic dopamine cell implant surgery with a placebo treatment. A total of 40 patients were recruited--half received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants. At present, this study is providing long-term follow-up evaluation and treatment for the subjects.

Being tested
embryonic dopamine cell implant surgery, placebo
Keywords
Parkinson's disease, PD, dopamine, embryonic dopamine cell implant surgery, tissue implants
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • embryonic dopamine cell implant surgeryProcedure or surgery

    Half of the participants received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants.

  • placeboProcedure or surgery

    sham surgery

Study groups in NCT00038116
Study groupRoleWhat they receive
embryonic dopamine cell implant surgeryActive comparatorembryonic dopamine cell implant surgery
Receives: Procedure: embryonic dopamine cell implant surgery
sham surgeryPlacebo comparatorsham surgery (placebo)
Receives: Procedure: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. a subjective Global Rating Scale

    Measured: duration of the trial

Secondary outcomes (1)

  1. objective measurements of PD, including UPDRS motor "off", Schwab and England "off", and 19F-fluorodopa uptake

    Measured: duration of the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2002 (estimated)
  2. Study startMay 1995
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00038116
Sponsor's protocol ID
93-0097
Status last verified
Mar 2010
First submitted
29 May 2002
Last updated
5 Feb 2013
Results posted
No

Publications

  • Freed CR, Greene PE, Breeze RE, Tsai WY, DuMouchel W, Kao R, Dillon S, Winfield H, Culver S, Trojanowski JQ, Eidelberg D, Fahn S. Transplantation of embryonic dopamine neurons for severe Parkinson's disease. N Engl J Med. 2001 Mar 8;344(10):710-9. doi: 10.1056/NEJM200103083441002.

    PubMed 11236774

  • Nakamura T, Dhawan V, Chaly T, Fukuda M, Ma Y, Breeze R, Greene P, Fahn S, Freed C, Eidelberg D. Blinded positron emission tomography study of dopamine cell implantation for Parkinson's disease. Ann Neurol. 2001 Aug;50(2):181-7. doi: 10.1002/ana.1075.

    PubMed 11506400

  • Ma Y, Feigin A, Dhawan V, Fukuda M, Shi Q, Greene P, Breeze R, Fahn S, Freed C, Eidelberg D. Dyskinesia after fetal cell transplantation for parkinsonism: a PET study. Ann Neurol. 2002 Nov;52(5):628-34. doi: 10.1002/ana.10359.

    PubMed 12402261

  • Trott CT, Fahn S, Greene P, Dillon S, Winfield H, Winfield L, Kao R, Eidelberg D, Freed CR, Breeze RE, Stern Y. Cognition following bilateral implants of embryonic dopamine neurons in PD: a double blind study. Neurology. 2003 Jun 24;60(12):1938-43. doi: 10.1212/01.wnl.0000070181.28651.3b.

    PubMed 12821736

  • Bjorklund A, Dunnett SB, Brundin P, Stoessl AJ, Freed CR, Breeze RE, Levivier M, Peschanski M, Studer L, Barker R. Neural transplantation for the treatment of Parkinson's disease. Lancet Neurol. 2003 Jul;2(7):437-45. doi: 10.1016/s1474-4422(03)00442-3. No abstract available.

    PubMed 12849125

  • Freed CR, Leehey MA, Zawada M, Bjugstad K, Thompson L, Breeze RE. Do patients with Parkinson's disease benefit from embryonic dopamine cell transplantation? J Neurol. 2003 Oct;250 Suppl 3:III44-6. doi: 10.1007/s00415-003-1308-5.

    PubMed 14579124

  • Gordon PH, Yu Q, Qualls C, Winfield H, Dillon S, Greene PE, Fahn S, Breeze RE, Freed CR, Pullman SL. Reaction time and movement time after embryonic cell implantation in Parkinson disease. Arch Neurol. 2004 Jun;61(6):858-61. doi: 10.1001/archneur.61.6.858.

    PubMed 15210522

  • McRae C, Cherin E, Yamazaki TG, Diem G, Vo AH, Russell D, Ellgring JH, Fahn S, Greene P, Dillon S, Winfield H, Bjugstad KB, Freed CR. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry. 2004 Apr;61(4):412-20. doi: 10.1001/archpsyc.61.4.412.

    PubMed 15066900

  • Ma Y, Tang C, Chaly T, Greene P, Breeze R, Fahn S, Freed C, Dhawan V, Eidelberg D. Dopamine cell implantation in Parkinson's disease: long-term clinical and (18)F-FDOPA PET outcomes. J Nucl Med. 2010 Jan;51(1):7-15. doi: 10.2967/jnumed.109.066811. Epub 2009 Dec 15.

    PubMed 20008998

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing embryonic dopamine cell implant surgery in people with Parkinson Disease, run by University of Colorado, Denver at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a subjective Global Rating Scale (time frame: duration of the trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00038116, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.

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