A phase IIa, unicenter, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrphic pseudoarthrosis of long bones

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. 18 to 85 years of age (male and female)
2. Atrophic or hypothrophic metaphyseal?diaphyseal pseudarthrosis of long bones, confirmed radiographically.
3. Informed Consent Form signed
4. The patient is able to understand the nature of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
2. Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
3. Significant abnormal laboratory tests that contraindicates patient?s participation in the study.
4. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
5. Smoker of more than 15 cigarettes a day
6. Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
7. Badly managed diabetes mellitus.
8. Patients diagnosed with peripheral arterial disorders
9. Previous therapeutic radiation (5 previus years) of the affected bone.
10. Neoplasia within the previous 5 years, or without remission
11. The patient is legally dependent
12. Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Phase IIb prospective, unicentric, randomized, parallel, double-blind, placebo-controlled clinical trial to evaluate the intravenous infusion of prostaglandins as therapy in patients with non-arteritic anterior ischemic optic neuropathy.

Phase 1

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Updated 9/26/2023

A clinical study to determine safety, tolerability and efficacy of drug called Evenamide which is taken orally, in patients with long standing schizophrenia getting inadequate benefit from their current antipsychotic medication.

CompletedPhase 2

ewron Pharmaceuticals SpA

Updated 6/24/2024

A clinical study to determine safety, tolerability and efficacy of drug called Evenamide which is taken orally, in patients with long standing schizophrenia getting inadequate benefit from their current antipsychotic medication.

CompletedPhase 2

ewron Pharmaceuticals SpA

Updated 11/24/2021

A phase-2, multi-centre, prospective, randomized, standard-of-care plus placebo-controlled, patient and central evaluator blinded, parallel arm, clinical study to evaluate safety, tolerability and efficacy of the recommended phase-2 dose of AUP1602-C in two dosing frequencies as a topical treatment for non-healing neuro-ischemic diabetic foot ulcers

RecruitingPhase 1

Aurealis Oy

Updated 7/22/2024

Multi center clinical study to evaluate the safety and efficacy of CB-03-01 for the treatment of female pattern hair loss, versus Minoxidil and placebo at different dosage of CB-03-01

Phase 1

Cassiopea S.p.A.

Updated 7/21/2021

Study of the efficacy and safety indicators of two different iron chelators in patients with iron overload (Estudio de los indicadores de eficacia y seguridad de dos quelantes del hierro en pacientes con sobrecarga ferrica)

Completed

Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)

Updated 1/13/2015

Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).

Phase 1

Guillem Cuatrecasas Cambra

Updated 5/29/2017

Study on the effect of vitamin D in women at high risk of developing breast cancer.

José Esteban Castelao Fernández

Updated 5/23/2012

A phase II, unicentre, randomized, double-blind, parallel and placebo-controlled, pilot study to evaluate the efficacy and safety of Somatuline Autogel (60 mg) in patients with active thyroid-associated ophthalmopaty of moderate intensity. Estudio piloto, de fase II, unicéntrico, aleatorizado, a doble ciego, paralelo y controlado con placebo para evaluar la eficacia y seguridad de Somatulina Autogel R (60 mg) en pacientes con oftalmopatía tiroidea activa de intensidad moderada

Phase 1

IPSEN PHARMA, S.A

Updated 4/19/2022

A phase IIa, single-center, randomized, reference-controlled, observer-blind trial to assess the efficacy of a topical Aescin formulation in experimentally induced itch, wheal and flare reactions in patients with type-I allergy

Marinomed Biotechnologie GmbH

Updated 2/18/2013

Recruitment & Eligibility

Study & Design

Related Trials

Phase IIb prospective, unicentric, randomized, parallel, double-blind, placebo-controlled clinical trial to evaluate the intravenous infusion of prostaglandins as therapy in patients with non-arteritic anterior ischemic optic neuropathy.

A clinical study to determine safety, tolerability and efficacy of drug called Evenamide which is taken orally, in patients with long standing schizophrenia getting inadequate benefit from their current antipsychotic medication.

A clinical study to determine safety, tolerability and efficacy of drug called Evenamide which is taken orally, in patients with long standing schizophrenia getting inadequate benefit from their current antipsychotic medication.

Multi center clinical study to evaluate the safety and efficacy of CB-03-01 for the treatment of female pattern hair loss, versus Minoxidil and placebo at different dosage of CB-03-01

Study of the efficacy and safety indicators of two different iron chelators in patients with iron overload (Estudio de los indicadores de eficacia y seguridad de dos quelantes del hierro en pacientes con sobrecarga ferrica)

Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).

Study on the effect of vitamin D in women at high risk of developing breast cancer.

A phase IIa, single-center, randomized, reference-controlled, observer-blind trial to assess the efficacy of a topical Aescin formulation in experimentally induced itch, wheal and flare reactions in patients with type-I allergy

Clinical Trial Alerts

Clinical Trial Alerts