Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

March 23, 2017 updated by: Bioheart, Inc.
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
  • daily pain for the previous 3 months
  • analgesics usage at least once a week
  • less than 30 minutes of morning stiffness
  • WOMAC score of ≤ 75 in the target knee
  • Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2

Exclusion Criteria:

  • evidence of secondary knee osteoarthritis
  • severe osteoarthritis (Joint space width - JSW < 2 mm)
  • prior intra articular injections within the previous one year prior to inclusion
  • patients with clinically significant systemic disease

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: SVF and PRP
Biological: Intra-articular injection of SVF plus PRP
administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Six minute walk distance
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Bioheart, Inc.

Collaborators

Anupam Hospital
RegennMed Research and Therapeutics Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 12, 2012

Primary Completion (Actual)

December 30, 2014

Study Completion (Actual)

December 30, 2014

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAH/02/12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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