Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis

NCT ID: NCT04314661

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2024-12-08

Brief Summary

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This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.

Detailed Description

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The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arthroscopy + Booster

After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.

Group Type EXPERIMENTAL

Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Intervention Type BIOLOGICAL

After Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Arthroscopy + Pre-Conditioning

After arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.

Group Type EXPERIMENTAL

Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

Intervention Type BIOLOGICAL

After Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Non Arthroscopy + Booster

Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.

Group Type EXPERIMENTAL

Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Intervention Type BIOLOGICAL

Without Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Non Arthroscopy + Pre-Conditioning

Without arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.

Group Type EXPERIMENTAL

Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

Intervention Type BIOLOGICAL

Without Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Interventions

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Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

After Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Intervention Type BIOLOGICAL

Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

After Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Intervention Type BIOLOGICAL

Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Without Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Intervention Type BIOLOGICAL

Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

Without Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Intervention Type BIOLOGICAL

Other Intervention Names

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Secretome

Eligibility Criteria

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Inclusion Criteria

* Patients aged 55-70 years
* Suffering from grade 2-3 OA was identified by two observers who differed accordingly Kellgren-Lawrence research scale
* Absence of local or general infections
* Haematological and biochemical analysis without significant changes being made cause contraindications
* Patients can understand the nature of the study
* Written informed consent is given to patients

Exclusion Criteria

* Patients are not willing to obey the study protocol
* There are signs of infection or positive serology for HIV, hepatitis and syphilis
* There is a history of cancer both in the family and yourself and the value of the examination tumour marker exceeds normal limits
* There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results
* Articular injection of the knee by any drug during the previous 3 months
* Participate in any clinical trial or treatment 30 days before the study
* Other conditions may, according to medical criteria, not support participation in this research
* Patients are subordinates or low ranking members
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PT. Prodia Stem Cell Indonesia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gatot Soebroto Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Yanuarso Yanuarso, Master

Role: CONTACT

081317128172

Cynthia Sartika, Doctor

Role: CONTACT

Facility Contacts

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Yanuarso, dr

Role: primary

08170147000

Viana

Role: backup

081317128172

Other Identifiers

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CT/OA/02/2022

Identifier Type: -

Identifier Source: org_study_id

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