NCT03827096: AMSC-DSD-001

Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease

Terminated Phase 1, PHASE2 Last updated 18 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Suspension of human autologous MSC 3P in 1.5 ml in Degenerative Disc Disease in 10 participants. Terminated before completion.

Timeline

27 August 2013

Primary endpoint
14 December 2016

14 December 2016

Quick facts

Lead sponsor	Bioinova, s.r.o.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	27 August 2013
Primary completion	14 December 2016
Estimated completion	14 December 2016

Drugs / interventions tested

• Suspension of human autologous MSC 3P in 1.5 ml — full drug profile →

Conditions studied

• Degenerative Disc Disease — all drugs for Degenerative Disc Disease →

Sponsor

Bioinova, s.r.o. — full company profile →

Who can join

Adults 18 to 55, any sex, with Degenerative Disc Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. After the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.

Publications & conference data

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

1. Development, Pathogenesis, and Regeneration of the Intervertebral Disc: Current and Future Insights Spanning Traditional to Omics Methods.
   Hickman TT, Rathan-Kumar S, Peck SH. · · 2022 · cited 40× · PMID 35359439 · DOI 10.3389/fcell.2022.841831
2. Stem Cells and Spinal Fusion.
   Stephan SR, Kanim LE, Bae HW. · · 2021 · cited 8× · PMID 34376498 · DOI 10.14444/8057