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

NCT ID: NCT03089762

Last Updated: 2017-03-27

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-12

Study Completion Date

2014-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SVF and PRP

Group Type EXPERIMENTAL

Intra-articular injection of SVF plus PRP

Intervention Type BIOLOGICAL

administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2

Interventions

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Intra-articular injection of SVF plus PRP

administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anupam Hospital

OTHER

Sponsor Role collaborator

RegennMed Research and Therapeutics Delhi

UNKNOWN

Sponsor Role collaborator

Bioheart, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Bansal H, Comella K, Leon J, Verma P, Agrawal D, Koka P, Ichim T. Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis. J Transl Med. 2017 Jun 19;15(1):141. doi: 10.1186/s12967-017-1242-4.

Reference Type DERIVED
PMID: 28629466 (View on PubMed)

Other Identifiers

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AAH/02/12

Identifier Type: -

Identifier Source: org_study_id

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