Degenerative Discopathy Involving L4-L5 Clinical Trial
Official title:
"Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease
| Verified date | January 2020 |
| Source | Banc de Sang i Teixits |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The present prospective, randomized study, compares the spinal fusion obtained after
instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from
his/her own bone marrow which will be fixed in human bone tissue form a donor), with the
current procedure that consists in instrumented spinal fusion and the use of each patient's
bone obtained from his/her iliac crest.
The working hypothesis proposes that the tissue engineering is a valid and useful technique
to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its
associated morbidity.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | October 21, 2019 |
| Est. primary completion date | May 3, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - L4-L5 degenerative spondylolisthesis grade I-II Meyerding isolated or associated to more than one level, and/or L4-L5 degenerative discopathy isolated or associated to more than one level. - 18 to 85 years of age (male and female) - Informed Consent Form signed - The patient is able to understand the nature of the study Exclusion Criteria: - Previous spine surgery - L4 isthmic spondylolisthesis - Smoker (more than 10 cigarettes a day) - Systemic or local infection - Patients treated with steroids (oral or systemic) within 3 months of entering the study, or treated with biphosphonates for more than 10 years - Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis. - Pregnant woman or intended to become pregnant, or breath feeding - Neoplasia within the previous 5 years, or without remission - Immunosuppressive states (except diabetes mellitus. Treatment with therapies is allowed) - Significant abnormal laboratory tests that contraindicates the surgery. - Participation in another clinical trial or treated with an investigational medicinal product the previous 3 months - Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria - The patient does not accept to be followed-up for a period that could exceed the clinical trial length - The patient is legally dependent |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital Vall d'Hebron | Barcelona | |
| Spain | Institut Universitari Dexeus (ICATME) | Barcelona | |
| Spain | Parc de Salut Mar | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Banc de Sang i Teixits | Ministerio de Ciencia e Innovación, Spain, Ministerio de Sanidad, Servicios Sociales e Igualdad, TFS Trial Form Support |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | safety of XCEL-MT-OSTEO-ALPHA (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) | Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months | 12 months | |
| Primary | Feasibility of XCEL-MT-OSTEO-ALPHA (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) | Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable. | 12 months | |
| Secondary | Efficacy spinal fusion by imaging procedures (X-Ray). | Spinal fusion will be assessed by spinal X-Ray | 3, 6 and 12 months | |
| Secondary | Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography) | Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography. | 6 and 12 months | |
| Secondary | Clinical outcomes (VAS) | Pain measurement by visual analogue scale (VAS) | 7 days and at 3, 6 and 12 months | |
| Secondary | Clinical outcomes (SF-36) | This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36 | 3, 6 and 12 months | |
| Secondary | Clinical outcome (Oswestry Disability Index) | To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index | 3, 6 and 12 months |