Bioactive formulation to treat osteoarthritis

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ARTROTX

Scientific title:

Evaluation of the intra-articular application of a bioactive formulation for the treatment of osteoarthritis: Clinical Trial Phase I-II

Acronym of Scientific Title:

ARTROTX

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

ESTERIPHARMA Foundation for Ethics, Education and Research for Cancer of the State Institute of Cancerology of Colima, A.C.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jose

Last name:

Valtierra-Alvarez

Medical Specialty :

Traumatology and orthopedics

Affiliation:

Medical center - hospital "Clinica Union"

Postal address:

Avenue Enrique Corona Morfin 90, Colonia La Frontera

City:

Villa de Alvarez, Colima

País:

Mexico

Zip Code:

28950

Telephone:

+52-3129437791

Email address:

dr_juanpaz@hotmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not applicable

Research ethics committees:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima), November 6th, 2015. (Central Ethics Committee)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

20/11/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Osteoarthritis of the knee, hip, shoulder, or jaw joints

Health condition(s) code:

Osteoarthritis

Arthritis

Joint Diseases

Musculoskeletal Diseases

Osteoarthritis, Hip

Osteoarthritis, Knee

Health condition keyword:

Osteoarthritis of the Jaw; Osteoarthritis of the shoulder

Intervention(s):

Bioactive Formula (US Patent 9089580 B1) (Experimental Group): Intra-articular application of the solution called bioactive formula in joint affected. The amount applied varies according to the joint: 2ml for knee or hip, 1.5ml for shoulder and 0.5ml for the mandibular joint. The procedure is performed on an outpatient basis and it is repeated at 30 and 60 days. Standard procedure (Control Group): Surgical replacement of joint with prosthesis.

Intervention code:

Injections, Intra-Articular

Joint Prosthesis

Surgical Procedures, Operative

Intervention keyword:

Bioactive formula

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Measurement time: baseline, at 3, 30, 60, 180 and 360 days. Therapeutic efficacy (improvement in quality of life index. Interrogation on joint pain intensity and quality of life). Measurement time: baseline, at 3, 30, 60, 180 and 360 days.

Key secondary outcomes:

Thickness of articular cartilage (Nuclear magnetic resonance of the treated joint to assess variations in thickness of articular cartilage). Measurement time: baseline, 4 and 12 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients older than 18 years. 2. Patients with clinical and radiographic diagnosis of osteoarthritis in the hip, knee, shoulder or mandible. 3. Patients with severe structural damage to their joint. 4. Severe and unproven articular symptomatology to conservative treatment and candidates for total joint arthroplasty (joint prosthesis placement). 5. Signature written informed consent of the patient

Exclusion criteria:

1. Rheumatoid arthritis 2. Autoimmune diseases 3. Decompensated systemic disease 4. Creatinine 1.25 times the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method). 5. Blood leucocytes less than 3000 cells / microliter or platelet count less than 100,000 / microliter. 6. Blood hemoglobin less than 10 g / deciliter. 7. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or onset of hematuria or proteinuria greater than 300 milligrams / day. 9. Pregnancy or women of childbearing potential without contraceptive method: salpingoclasia, device or hormonal. Breastfeeding women. 10. Alcoholism and / or drug addiction. 11. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin). 12. Presence of: Cancer 13. Other pathologies at the discretion of the researcher

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

252

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivan

Last Name:

Delgado-Enciso

Specialty:

General Medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

País:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email :

ivancoliman@hotmail.com

ivan_delgado_enciso@ucol.mx

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Brenda

Middle Name:

Astrid

Last Name:

Paz-Michel

Specialty:

Biomedical Research

Affiliation:

ESTERIPHARMA

Postal Address:

Avenue Patricio Sanz 1582, Colonia del Valle Centro

City:

Mexico City

País:

Mexico

Zip Code:

03100

Telephone:

+52 55-50613500

Email :

brendapazmichel@gmail.com

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000250

Date of Registration in Primary Registry:

15/08/2017

Record Verification Date:

2020/08/28

Next update date:

2021/08/28

Link to the spanish version:

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Bioactive formulation to treat osteoarthritis

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