Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis

March 15, 2020 updated by: Stem Cells Arabia

Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis

Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis ultimately results in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has anti-inflammatory and regenerative effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of BM-SC transplantation in treatment of rheumatoid arthritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects joints. It typically results in swollen and painful joints. Pain and stiffness often worsen after rest. Most frequently, the wrist and hands are involved, with the same joints typically involved on both sides of the body. RA affects between 0.5-1% of adults in the developed world with between 5-50 per 100,000 people newly developing the disease each year. Onset is most frequent during middle age and women are affected 2.5 times as frequently as men. The goal of treatment is to reduce pain, decrease inflammation, and improve a person's overall functioning and quality of life.

Herein, the investigators study the safety and efficacy of the immunomodulatory effects of bone marrow-derived stem cells administered intravenously and the regenerative and repair potential of bone marrow-derived stem cells transplanted into the joints of patients with RA.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 17-75 years old
  • The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before treatment.

Exclusion Criteria:

  • Subjects with addition major health condition/disease diagnoses
  • Subjects that are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stem Cells
Autologous bone marrow-derived stem cell transplantation.
Biological: Stem Cell Transplantation
  • Intravenous administration of autologous bone marrow derived stem cells for immunomodulation.
  • Transplantation of autologous bone marrow derived stem cells in joints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Pain Reduction measured by VAS scaling
Time Frame: 1 month
measured by VAS scaling
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the Physical Activity measure by WOMAC scoring
Time Frame: 1 month
1 month
Evaluation the resurfacing of articular cartilage by MRI
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Cells Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

February 25, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA-RA1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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