SAFETY AND EFFECTIVENESS OF INTRAARTICULAR ADMINISTRATION OF ADIPOSE-DERIVED STROMAL VASCULAR FRACTION FOR TREATMENT OF KNEE ARTICULAR CARTILAGE DEGENERATIVE DAMAGE: PRELIMINARY RESULTS OF A CLINICAL TRIAL

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Abstract

The incidence of knee osteoarthritis tends to increase every year and constitutes more than 83% of overall OA morbidity. Moreover, the OA morbidity among younger patients is also increasing. However, currently available treatment methods do not provide quite satisfactory outcomes.

Purpose of the study – to evaluate safety and efficacy of intraarticular introduction of autologous adipose-derived stromal vascular fraction for treatment of knee osteoarthritis.

Material and methods. By the moment of writing the present report, 28 patients were included into the study. All patients underwent tumescent liposuction under local anesthesia. The stromal vascular fraction was isolated from lipoaspirate within 1,5 hours after harvesting and subsequently injected into the articular cavity. Follow-up period was 6 months after injections. The authors report on efficacy data of 10 patients who completed the study according to protocol and safety data of all 28 patients. Efficacy was evaluated basing on laboratory assessments and patient’s subjective assessment by validated questionnaires.

Results. Neither adverse reactions no adverse events were observed. Significant decrease of pain severity by VAS was noted in one week after injection and pain score continued decreasing during the whole follow up period. The increase of KOOS score was noted starting on the fifth week after injection. KSS part 1 score increased in 8 weeks, KSS part 2 score — in 6 months after injection. Physical health, assessed with SF-36 questionnaire significantly improved in 2 and 6 months after the procedure. There was a clear trend towards improvement of mental health.

Conclusion. Preliminary results of clinical study suggest intraarticular injection of autologous adipose-derived stromal vascular fraction to be a safe and efficient method of the treatment of knee osteoarthritis. 

About the authors

I. A. Smyshlyaev

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation;
Central State Medical Academy, Administrative Department of the President of the Russian Federation

Author for correspondence.
Email: mutant89@rambler.ru

Ivan A. Smyshlyaev — Orthopedic Surgeon, Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation; Graduate Student, Central State Medical Academy, Administrative Department of the President of the Russian Federation 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

S. I. Gilfanov

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation;
Central State Medical Academy, Administrative Department of the President of the Russian Federation;
Peoples’ Friendship University of Russia

Email: fake@neicon.ru
Sergey I. Gilfanov — Dr. Sci. (Med.), professor, Head of the Traumatology and Orthopedics Department, Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation; Head of Chair of Traumatology and Orthopedics, Central State Medical Academy, Administrative Department of the President of the Russian Federation; Peoples’ Friendship University of Russia Россия

V. A. Kopylov

Orenburg City Clinical Hospital N 4

Email: fake@neicon.ru

Vadim A. Kopylov — Cand. Sci. (Med.), Head of the Surgic Department 

11, ul. Postnikova, Orenburg, 460000

Россия

R. G. Gilmutdinov

Orenburg Regional Clinical Donor Blood Center

Email: fake@neicon.ru

Rinat G. Gilmutdinov — Cand. Sci. (Med.), Chief Medical Officer 

32, ul. Aksakova, Orenburg, 460018

Россия

I. I. Pulin

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Andrey A. Pulin — Cand. Sci. (Med.), Head of the Laboratory of Cell Technologies of the Center for Biomedical Technologies 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

I. N. Korsakov

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Ivan N. Korsakov — Cand. Sci. (Med.), Head of the Laboratory of Tissue Engeeniring of the Center for Biomedical Technologies 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

I. R. Gilmutdinova

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Ilmira R. Gilmutdinova — Cand. Sci. (Med.), transfusiologist of Cryobank of the Center for Biomedical Technologies 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

A. P. Petrikina

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Anastasiya P. Petrikina – Laboratory Diagnostics Laboratory of Cell Technologies of the Center for Biomedical Technologies 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

P. S. Eremin

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Petr S. Eremin – Biologist of Laboratory of Cell Technologies of the Center for Biomedical Technologies 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

O. V. Kruchkova

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Oksana V. Kruchkova – Cand. Sci. (Med.), Head of the Department of X-ray Diagnostics and Tomography 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

V. P. Abeltsev

Joined Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Vladimir P. Abeltsev — Dr. Sci. (Med.), professor Head of the Department of Traumatology and Orthopedics 

6, Michurinskii pr-t, Moscow,119285

Россия

N. V. Zagorodniy

Peoples’ Friendship University of Russia

Email: fake@neicon.ru

Nikolay V. Zagorodniy — Dr. Sci. (Med.), professor, Head of the Department of Traumatology and Orthopedics 

6, ul. Miklukho-Maklaya, Moscow, 117198

Россия

V. L. Zorin

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Vadim L. Zorin – Cand. Sci. (Biol.), biologist of Laboratory of Cell Technologies of the Center for Biomedical Technologies 

15, ul. Marshala Timoshenko, Moscow, 121359

Россия

V. S. Vasilyev

South Ural State Medical University

Email: fake@neicon.ru

Vyacheslav S. Vasilyev – Cand. Sci. (Med.), Assistant of the Department of Plastic Surgery and Cosmetology 

64, ul. Vorovskogo, Chelyabinsk, 454048

Россия

D. Yu. Pupynin

Orenburg City Clinical Hospital N 4

Email: fake@neicon.ru

Dmitry Yu. Pupynin — Chief Medical Officer 

11, ul. Postnikova, Orenburg, 460000

Россия

I. I. Eremin

Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation;
Central State Medical Academy, Administrative Department of the President of the Russian Federation

Email: fake@neicon.ru

Il’ya I. Eremin – Cand. Sci. (Med.), Head of Center for Biomedical Technologies, Central Clinical Hospital with Outpatient Health Center, Administrative Department of the President of the Russian Federation; Assistant Professor, Department of Health Organization and Public health, restorative medicine and medical rehabilitation, Central State Medical Academy, Administrative Department of the President of the Russian Federation

Россия

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