RETRACTED ARTICLE: Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis
Authors: Kristin Comella
Diwaker Agrawal
Poonam Verma
Himanshu Bansal
Prasad Koka
Jerry Leon
Thomas Ichim
Journal: Journal of Translational Medicine (2017)
Discipline: CLINICAL MEDICINE
Keywords: Adipose derived stromal/stem cells (ADSCs); Adipose tissue; Cell therapy; Connective tissue; Osteoarthritis
Affiliations: Mother Cell Spinal Injury & Stem Cell Research, Anupam Hospital, Second Floor, Kashipur Bypass Road, Rudrapur, Uttarakhand, 263153, India. ., US Stem Cell, Inc, Sunrise, FL, USA., Advance Health Institute Mayaguez, Puerto Rico, USA., RegennMed Research and Therapeutics LLP, Chattarpur, Delhi, India., Mercy Medical Centre, Roseburg, OR, USA., Department of Virology and Immunology, Haffkine Institute, Mumbai, Maharashtra, 400012, India., Regenerative Medicine Institute, Tijuana, Mexico.

Abstract:  Background: 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. We evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2. Methods: A total of ten patients underwent a local tumescent liposuction procedure to remove approximately 100 ml of fat tissue from the abdomen. SVF was isolated using an enzyme digestion and resuspended in PRP for intra-articular injection in the knee. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and six-minute walk distance (6MWD) were used to evaluate clinical effects and included measure of patient's subjective assessment of pain, joint mobility, and physical disability. WOMAC score, 6MWD and laboratory tests were repeated at 3 and 6 months and 1, 1.5 and 2 years. XRAY and MRI were completed at 1 year. Results: The average total WOMAC score was 64 at baseline and significantly reduced to 52 at 3 months, 46 at 6 months, 42 at 1 year, 38 at 1.5 years, and 41 at 2 years. Patients walked an average of 1310 feet at baseline and demonstrated a statistically significant improvement at 3 and 6 months and 1, 1.5, and 2 years post treatment. Cartilage thickness as determined by MRI improved by at least 0.2 mm in six patients, was unchanged in two patients and decreased by at least 0.2 mm in two patients. Conclusions: Overall, all of the patients were pleased with the treatment results. They reported a reduction in pain levels, especially after 3 months. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications reported. Trial registration NCT03089762; Name of registry: http://www.clinicaltrials.gov. 

Retracted: Yes

PubPeer comments:
 Possible duplication of Figure 1 in two articles. J Transl Med. 2017 Jan 13;15(1):12. doi: 10.1186 s12967-016-1109-0. J Transl Med. 2016 Jun 2;14(1):158. doi: 10.1186 s12967-016-0918-5.   , 
 Himashu Bansal? http: blogs.discovermagazine.com neuroskeptic 2017 03 17 unethical-stem-cell-therapy-for-autism-in-india #.XPgkChYzbtQ Kristin Comella? https: www.latimes.com business hiltzik la-fi-hiltzik-us-stem-cell-20180427-story.html , 
  **Ethics approval and consent to participate** The trial was approved by the ethics committee of Anupam Hospital called the Institutional Committee for Stem Cell Research and Therapy (Trial AAH 02 12). This is Anupam Hospital where [Bansal operates a penis-enlargement clinic] .  The  Institutional Committee for Stem Cell Research and Therapy appears to consist of Himanshu Bansal. There is no record of Clinical Trial registration in India. The US Clinical Trial registration serves no purpose except to shed legitimacy on this research. https: www.clinicaltrials.gov ct2 show NCT03089762?term=NCT03089762 rank=1 , 
 The illustrative MRIs are unlikely to come from patients involved in this study, since according to the time-stamps they hail from dates ranging from 2010 to 2013.   I am also skeptical that Himanshu Bansal has MRI facilities in his penis-enlargement clinic. , 
 Retracted [26 April 2021] . -------------------------------------------- The Editor-in-Chief has retracted this article [1] due to a number of concerns that have come to light after publication. The clinical trial registry [2] for this study states that the study start date is 12 February 2012. However, documentation regarding the ethical approval provided by the corresponding author shows that the authors applied for ethics approval on 18 February 2012, and that the ethics committee approved the study on 17 September 2012. Additionally, the time stamp on Fig. 4a is 11 September 2012 and on Fig. 4b itu2019s 27 February 2010, which suggests the research was conducted before ethics approval was obtained. The Editor-in-Chief therefore no longer has confidence in the reliability of the data reported in the article. Prasad Koka agrees to this retraction. Himanshu Bansal, Kristin Comella and Thomas Ichim do not agree to this retraction. Jerry Leon, Poonam Verma and Diwaker Agrawal have not responded to any correspondence from the editor publisher about this retraction. , 
 See also https: retractionwatch.com 2021 04 30 paper-partly-funded-by-controversial-stem-cell-company-retracted ,