NCT02683629

A Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease

Completed Phase 2 Last updated 12 May 2019

What this trial tests

Phase 2 trial testing NTCELL Implantation in Parkinson's Disease in 18 participants. Completed in 2 May 2019.

Timeline

1 February 2016

Primary endpoint
1 October 2017

2 May 2019

Quick facts

Lead sponsor	Living Cell Technologies
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	18
Start date	1 February 2016
Primary completion	1 October 2017
Estimated completion	2 May 2019
Sites	1 location across New Zealand

Drugs / interventions tested

• NTCELL Implantation — full drug profile →
• Sham Surgery

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

Living Cell Technologies — full company profile →

Who can join

Adults 40 to 65, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The safety of xenotransplantation of NTCELL as measured by the incidence of adverse events related to treatment
  Time frame: up to 26 weeks
  Adverse events can result from, for example, abnormal clinical laboratory tests (including xenogeneic viral analysis), abnormal physical examination findings, any abnormal findings following review by an infectious disease physician. These multiple assessments result in the one outcome measure which is the incidence of treatment emergent adverse events

Sponsor's own description

To assess the safety of xenotransplantation of NTCELL \[immunoprotected (alginate-encapsulated) choroid plexus cells\] in patients with Parkinson's disease, assessed over the duration of the study, by monitoring the occurrence of adverse events and serious adverse events, including clinical and laboratory evidence of xenogeneic infection in transplant recipients and their partners/close contacts. Subsequent safety follow-up will include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.

To assess the efficacy of xenotransplantation of NTCELL \[immunoprotected (alginate-encapsulated) choroid plexus cells\] in patients with Parkinson's disease. This will be quantified by testing the secondary endpoints of the trial as described below (see Endpoints/Outcome Measures).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modulating Alginate Hydrogels for Improved Biological Performance as Cellular 3D Microenvironments.
   Neves MI, Moroni L, Barrias CC. · · 2020 · cited 122× · PMID 32695759 · DOI 10.3389/fbioe.2020.00665
2. Current Therapies in Clinical Trials of Parkinson's Disease: A 2021 Update.
   Prasad EM, Hung SY. · · 2021 · cited 66× · PMID 34451813 · DOI 10.3390/ph14080717
3. Corneal xenotransplantation: Where are we standing?
   Yoon CH, Choi HJ, Kim MK. · · 2021 · cited 57× · PMID 32755676 · DOI 10.1016/j.preteyeres.2020.100876
4. Is the Immunological Response a Bottleneck for Cell Therapy in Neurodegenerative Diseases?
   Salado-Manzano C, Perpiña U, Straccia M, Molina-Ruiz FJ, et al · · 2020 · cited 25× · PMID 32848630 · DOI 10.3389/fncel.2020.00250