Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion

• Sponsor: Bone Therapeutics S.A (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02205138
• Collaborator: (none)
• Enrollment: 38
• Locations: 8
• Arm: 1
• Duration (Months): 75.8
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and functional improvement. However, pseudarthrosis and failure to relieve low back pain are unfortunately still frequent, irrespective of the type of procedures and grafts used by the surgeon.

The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease	Drug: ALLOB® cells with ceramic scaffold	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Lumbar Spinal Fusion
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Jan 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALLOB® cells with ceramic scaffold ALLOB® cells with ceramic scaffold Implantation	Drug: ALLOB® cells with ceramic scaffold; Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia

Outcome Measures

Primary Outcome Measures

1. Lumbar fusion progression as assessed by CT scan [12 months]

2. Functional Disability using Oswestry Disability Index [12 months]

3. Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements [12 months]

Secondary Outcome Measures

1. Pain using a Visual Analogue Scale [12 months]

2. Global Disease Evaluation using a Visual Analogue Scale [12 months]

3. Functional Disability using Oswestry Disability Index [12 months]

4. Lumbar fusion progression as assessed by CT scan [12 months]

5. Percentage of patients having a rescue surgery [12 months]

6. Potential occurrence of any AE or SAE related to the product or to the procedure [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements

• Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1)

• Unresponsive to non-operative treatment for at least 6 months

Exclusion Criteria:

• Lumbar disc disease requiring treatment at more than one level

• Previous failed fusion at the involved lumbar level

• Local active or latent infection at the involved lumbar level

• Positive serology for hepatitis B, hepatitis C, HIV

• Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigating site BE01	Brussels		Belgium
2	Investigating site BE03	Brussels		Belgium
3	Investigating site BE05	Brussels		Belgium
4	Investigating site BE02	Charleroi		Belgium
5	Investigating site BE04	Genk		Belgium
6	Investigating site BE08	Kortrijk		Belgium
7	Investigating site BE07	Liège		Belgium
8	Investigating site BE06	Mons		Belgium

Sponsors and Collaborators

• Bone Therapeutics S.A

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bone Therapeutics S.A
• ClinicalTrials.gov Identifier: NCT02205138
• Other Study ID Numbers: ALLOB-IF1
• First Posted: Jul 31, 2014
• Last Update Posted: Jan 29, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Bone Therapeutics S.A: Spinal Fusion; Lumbar Interbody Fusion; Degenerative Disc Disease; Cell Therapy; Bone Graft
• Additional relevant MeSH terms: Intervertebral Disc Degeneration

Study Results

No Results Posted as of Jan 29, 2021