Autologous bone marrow–derived CD133 cells with core decompression as a novel treatment method for femoral head osteonecrosis: a pilot study

Emadedin, Mohsen; Karimi, Shahedeh; Karimi, Aliasghar; Labibzadeh, Narges; Niknejadi, Maryam; Baharvand, Hossein; Aghdami, Nasser

doi:10.1016/j.jcyt.2018.10.005

Cited by 12 publications

(8 citation statements)

References 30 publications

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“…This meta-analysis showed that therapy with stem cells for early-stage ONFH could significantly have better outcomes on preventing collapse of femoral head and delaying the time for THR in the long term contributing to a better survival. Safety analysis also showed that there were fewer adverse events such as pain, fever, and nausea by adopting this therapy [20,[22][23][24], which was also supported by several other studies [13,41,42]. Besides, compared with control groups, we found that a significant difference was existed on the collapse of femoral head during follow-up of more than 60 months and THR head more than 36 months.…”

Section: Discussionsupporting

confidence: 82%

“…Several previous studies [12,13,21,35] focused on cell therapies have found that there was a clinical improvement of symptoms on patients with ONFH including pain and function scores. However, the efficacy of stem cells in the long term is not clear and remains controversial especially on the progression events [9,11,12,36,37].…”

Section: Discussionmentioning

confidence: 98%

“…Hernigou et al [ 7 ] first implanted autologous bone marrow stem cells (BMSCs) into necrotic area of femoral head and found that patients had better outcomes if they received larger number of progenitor cells. There are several procedures of various stem cell therapies including combining stem cells with CD, autologous bone graft, platelet-rich plasma, or supporting biomaterial implantation [ 8 – 13 ]. Several studies [ 12 , 14 , 15 ] also confirmed that stem cells could effectively improve early-stage ONFH patients’ symptoms such as pain and hip function in the short term.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of stem cell therapy for the early-stage osteonecrosis of femoral head: a systematic review and meta-analysis of randomized controlled trials

et al. 2020

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Background Osteonecrosis of femoral head (ONFH) is a seriously degenerative disease with no effective therapies to slow its progression. Several studies have reported short-term efficacy of stem cells on early-stage ONFH. However, its long-term effect was still unclear especially on progression events. This study was performed to evaluate the long-term efficacy and safety of stem cells and analyze its optimal age group and cell number. Methods Our review was registered on PROSPERO (http://www.crd.york.ac.uk/PROSPERO), registration number CRD42020136094. Following PRISMA guideline, we searched 8 electronic databases on January 5, 2020, and rigorous random controlled trials (RCTs) utilizing stem cell therapy on early-stage ONFH were included. Quality and bias were analyzed. Pooled analysis was performed to assess difference between various outcomes. Results A total of 13 RCTs (619 patients with 855 hips) were included. The application of stem cells significantly delayed collapse of femoral head(I2, 70%; RR, 0.54; 95% CI, 0.33 to 0.89; P < .00001) and total hip replacement (THR) (I2, 68%; RR, 0.55; 95% CI, 0.34 to 0.90; P = .02) in the long term. It effectively decreased the events of collapse of femoral head (≥ 60 months) (I2, 0%; RR, 0.37; 95% CI, 0.28 to 0.49; P < .00001) and THR (> 36 months) (I2, 0%; RR, 0.32; 95% CI, 0.23 to 0.44; P < .00001). There existed a beneficial effect for patients under 40 (Collapse of femoral head: I2, 56%; RR, 0.41; 95% CI, 0.23 to 0.76; P = .004) (THR: I2, 0%; RR, 0.31; 95% CI, 0.23 to 0.42; P < .00001). In addition, quantity of stem cells at 108 magnitude had better effects on disease progression events (I2, 0%; RR, 0.34; 95%CI, 0.16 to 0.74; P = .007). Besides, there were no significant differences on adverse events between the stem cell group and control group (I2, 0%; RR, 0.82; 95% CI, 0.39 to 1.73; P = .60). Conclusion Our findings build solid evidence that stem cell therapy could be expected to have a long-term effect on preventing early-stage ONFH patients from progression events, such as collapse of femoral head and total hip replacement. Furthermore, patients under 40 may be an ideal age group and the optimal cell number could be at 108 magnitude for this therapy. Further studies including strict RCTs are required to evaluate a clear effect of stem cells on ideal patient profile and the procedures of implantation.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of stem cell therapy for the early-stage osteonecrosis of femoral head: a systematic review and meta-analysis of randomized controlled trials

et al. 2020

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“…If the patient walks well autonomously, it is sufficient to show that the patient can complete basic daily activities such as going up and down the stairs and taking busses. For this reason, walking distance is used as an independent evaluation indicator in many studies [35, 36].…”

Section: Discussionmentioning

confidence: 99%

How to evaluate the clinical outcome of joint-preserving treatment for osteonecrosis of the femoral head: development of a core outcome set

Xue

Sun

et al. 2019

J Orthop Surg Res

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Background This study aimed to develop a core outcome set (COS) for clinical trials of joint-preserving treatment for osteonecrosis of the femoral head (ONFH), that is, to define a minimal set of outcomes that should be reported in such trials. Methods A mixed research method was adopted in this study. First, clinical trials of hip preservation therapy were systematically researched and analyzed. Second, a three-round Delphi survey involving both doctors and patients was carried out to obtain the core outcome indicators. Round 1 was a modified Delphi questionnaire for doctors and patients to determine which outcomes are important to these stakeholders, round 2 determined what clinical evaluation core outcomes should be included for the joint-preserving treatment of ONFH, and round 3 determined how core outcomes should be measured. Finally, a consensus meeting was held to discuss and vote on the established COS. Results The results of the systematic review showed that 42 outcome indicators were classified according to common signs and symptoms, quality of life, long-term outcomes, radiological evaluation, blood biochemistry, and indexes of safety. The three rounds of Delphi surveys completed the selection of indicators for the COS and the determination of the corresponding measurements. A total of 73 orthopedic doctors and 103 patients participated in round 1, and the top 10 indicators selected were basically the same. In round 2, 32 experts identified the following indicators: pain, range of motion (ROM) of hip flexion, walking distance, and stable rating of X-ray images. In round 3, 35 experts defined the measurement of each indicator. Finally, the consensus meeting identified the four indicators aforementioned that constituted the COS. The scores for pain, ROM of hip flexion, and walking distance are from 0 to 10; 0 represents the best scores, while 10 represents the most serious impairment. The stable rating of X-ray images is determined by the morphology of the femoral head and the change in the density of the necrotic area. Conclusions We established a COS for hip-preserving treatment of ONFH that includes four indicators: pain, ROM of hip flexion, walking distance, and stable rating of X-ray images.

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“…After 20–30 years follow-up, it was reported that core decompression with bone marrow cell injection improved the outcome of the disease (with less hip replacements) as compared with core decompression alone in the same patient group (Hernigou et al, 2018). Recently, injections of magnetically-separated CD133 positive bone marrow progenitors in 9 patients with femoral head osteonecrosis resulted in improved disease scores, less joint injuries, and provided clinically-relevant pain relief (Emadedin et al, 2019). In contrast, Hauzeur et al reported that implantation of concentrated bone marrow MNCs after core decompression did not produce any improvement in the progression of stage 3 non-traumatic osteonecrosis of the femoral head (Hauzeur et al, 2018).…”

Section: Mscs-based Therapies and Bone Tissue Engineeringmentioning

confidence: 99%

Mesenchymal Stromal Cell-Based Bone Regeneration Therapies: From Cell Transplantation and Tissue Engineering to Therapeutic Secretomes and Extracellular Vesicles

Presen

Traweger

Gimona

et al. 2019

Front. Bioeng. Biotechnol.

110

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Effective regeneration of bone defects often presents significant challenges, particularly in patients with decreased tissue regeneration capacity due to extensive trauma, disease, and/or advanced age. A number of studies have focused on enhancing bone regeneration by applying mesenchymal stromal cells (MSCs) or MSC-based bone tissue engineering strategies. However, translation of these approaches from basic research findings to clinical use has been hampered by the limited understanding of MSC therapeutic actions and complexities, as well as costs related to the manufacturing, regulatory approval, and clinical use of living cells and engineered tissues. More recently, a shift from the view of MSCs directly contributing to tissue regeneration toward appreciating MSCs as “cell factories” that secrete a variety of bioactive molecules and extracellular vesicles with trophic and immunomodulatory activities has steered research into new MSC-based, “cell-free” therapeutic modalities. The current review recapitulates recent developments, challenges, and future perspectives of these various MSC-based bone tissue engineering and regeneration strategies.

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Autologous bone marrow–derived CD133 cells with core decompression as a novel treatment method for femoral head osteonecrosis: a pilot study

Cited by 12 publications

References 30 publications

Efficacy and safety of stem cell therapy for the early-stage osteonecrosis of femoral head: a systematic review and meta-analysis of randomized controlled trials

Efficacy and safety of stem cell therapy for the early-stage osteonecrosis of femoral head: a systematic review and meta-analysis of randomized controlled trials

How to evaluate the clinical outcome of joint-preserving treatment for osteonecrosis of the femoral head: development of a core outcome set

Mesenchymal Stromal Cell-Based Bone Regeneration Therapies: From Cell Transplantation and Tissue Engineering to Therapeutic Secretomes and Extracellular Vesicles

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